Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000727326 | |||
| NCI-2012-00700 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to risk group (see Disease Characteristics) and type of radiation therapy (RT) boost (intensity-modulated RT (IMRT) vs brachytherapy). Patients are randomized to 1 of 2 treatment arms.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADT + RT | Active Comparator | Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. |
|
| TAK-700 + ADT + RT | Experimental | TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH agonist | Drug | LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol) | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from primary (original protocol) to secondary. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 5-year rates are provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Ethnicity | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. |
Inclusion Criteria:
Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations:
History/physical examination within 60 days prior to registration.
Clinically negative lymph nodes as established by imaging [abdominal and/or pelvic computerized tomography (CT) or abdominal and/or pelvic magnetic resonance imaging (MRI)], nodal sampling, or dissection within 90 days prior to registration.
•Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0 cm.
No distant metastases (M0) on bone scan within 90 days prior to registration (18F-Na bone scan is an acceptable substitute).
•Equivocal bone scan findings are allowed if plain films are negative for metastasis.
Baseline serum prostate-specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) or anti-androgen therapy, within 180 days of randomization.
Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy), may have been started prior to registration, provided that registration is within 50 days of beginning ADT. Please note: If the patient has started ADT he will not be eligible to participate in the quality of life component of this study.
Prior testosterone administration is allowed if last administered at least 90 days prior to registration.
Zubrod Performance Status 0-1 within 21 days prior to registration
Age ≥ 18
Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows:
Serum creatinine < 2.0 mg/dl and creatinine clearance (can be calculated) > 40 mL/minute within 21 days prior to registration
Bilirubin < 1.5x upper limit of normal (ULN) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5x ULN within 21 days prior to registration
Serum testosterone within 21 days prior to registration
Chemistry (including sodium, potassium, chloride, bicarbonate (carbon dioxide), blood urea nitrogen (BUN), glucose, calcium, magnesium and phosphorous) and liver panels (including albumin and alkaline phosphatase) obtained within 21 days prior to registration
Fasting glucose, fasting insulin, lipid panel [cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL)], and Hemoglobin A1C within 21 days prior to registration
Screening calculated ejection fraction of ≥ to institutional lower limit of normal by multiple gated acquisition (MUGA) scan or by echocardiogram (ECHO).
Baseline electrocardiogram (ECG) within 180 days prior to registration
Patients, even if surgically sterilized (ie, status post vasectomy), who:
Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria:
PSA > 150
Definite evidence of metastatic disease.
Pathologically positive lymph nodes or nodes > 2.0 cm on imaging.
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.
•Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume <60 cc, American Urological Association (AUA) score ≤15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive external beam radiation therapy [EBRT] only).
Previous hormonal therapy for > 50 days.
Known hypersensitivity to TAK-700 or related compounds
A history of adrenal insufficiency
History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 [NCI CTCAE, version 4.02] (U.S. Department of Health and Human Services, National Institutes of Health National Cancer Institute, 2009), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to registration. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
New York Heart Association Class III or IV heart failure.
ECG abnormalities of:
Patients who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Prior allergic reaction to the drugs involved in this protocol.
Study entry PSA obtained during the following time frames:
Cushing's syndrome
Severe chronic renal disease (serum creatinine > 2.0 mg/dl and confirmed by creatinine clearance < 40 mL/minute)
Chronic liver disease (bilirubin > 1.5x ULN, ALT or AST > 2.5x ULN)
Chronic treatment with glucocorticoids within one year
Uncontrolled hypertension despite appropriate medical therapy within 21 days prior to registration (blood pressure of greater than 150 mm Hg systolic and 90 mm Hg diastolic at 2 separate measurements no more than 60 minutes apart during Screening visit)
Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
Major surgery within 14 days prior to registration
Serious infection within 14 days prior to registration
Uncontrolled nausea, vomiting, or diarrhea [Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3] despite appropriate medical therapy at the time of registration
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| M. Dror Michaelson, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic at Acton Road | Birmingham | Alabama | 35243 | United States | ||
| University of Alabama at Birmingham |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ADT + RT | Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. |
| FG001 | TAK-700 + ADT + RT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Anti-androgen | Drug | Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day). |
|
|
| TAK-700 | Drug | 300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT. |
|
| Radiation therapy | Radiation | Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy. |
|
| From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Percentage of Participants With Grade 3 or Higher Adverse Events | Time to grade 3 or higher adverse event (event) is defined as time from randomization to the date of first event, last known follow-up (censored), or death without failure (competing risk). Event rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Percentage of Participants With Local Progression | Local recurrence (failure) is defined as biopsy proven recurrence within the prostate gland. Time to failure is defined as time from randomization to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates reported. |
| Percentage of Participants With Distant Metastases | Distant metastases (failure) is defined as imaging or biopsy demonstrated evidence for systemic recurrence. Biopsy was not required, however it was encouraged in absence of a rising PSA. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. Note, the protocol lists this endpoint as regional or distant metastasis, but regional progression data was not collected. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Percentage of Participants With General Clinical Treatment Failure | General clinical treatment failure (GCTF) is defined as: PSA > 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of salvage androgen deprivation therapy. Failure time is defined as time from registration to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Percentage of Participants With Death Due to Prostate Cancer | Time to prostate cancer death is defined as time from randomization to the date of death due to prostate cancer, last known follow-up (censored), or death due to other causes (competing risk). Failure rates were to be estimated using the cumulative incidence method. If too few events occur for meaningful estimates, then only counts of events will be reported. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year | The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year. | Baseline, one year |
| Change in Patient-reported Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Short Form at One Year | The EPIC-Short Form is a 26-item, validated self-administered tool to assess disease-specific aspects of prostate cancer and its therapies consisting of five summary domains (bowel, urinary incontinence, urinary irritation/obstruction, sexual, and hormonal function). Responses for each item form a Likert scale which are transformed to a 0-100 scale. A domain score is the average of the transformed domain item scores, ranging from 0-100 with higher scores representing better health-related quality of life (HRQOL). Change at one year is defined as one-year value - baseline value. Positive change at one year indicates improved quality of life. | Baseline, one year |
| Serum Testosterone | Baseline,12 months, 24 months |
| Fasting Total Cholesterol | Baseline, 12 months, 24 months |
| Serum High-density Lipoprotein (HDL) | Baseline, 12 months, 24 months |
| Serum High-density Lipoprotein (LDL) | Baseline, 12 months, 24 months |
| Hemoglobin A1c | Baseline, 12 months, 24 months |
| Fasting Plasma Glucose | Baseline, 12 months, 24 months |
| Fasting Plasma Insulin | Baseline, 12 months, 24 months |
| Change From Baseline in Body Mass Index (BMI) | Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). Change from baseline = time point value - baseline value. | Baseline and yearly to five years. |
| Number of Participants by Highest Grade Adverse Event | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data | From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Testosterone Recovery at 12 and 24 Months | Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Time to testosterone recovery is defined as time from randomization to the date of testosterone recovery, biochemical, local, or distant failure (competing risk), salvage therapy (competing risk), death (competing risk), or last known follow-up (censored). Testosterone recovery rates are estimated using the cumulative incidence method. | From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. |
| Median Testosterone Recovery Time | Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Testosterone recovery rates are estimated using the Kaplan-Meier method, censoring for biochemical, local, or distant failure, salvage therapy, death, and otherwise alive without event. Testosterone recovery time is defined as time from randomization to testosterone recovery or censoring. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Number of Patients With Clinical Survivorship Events | Clinical survivorship events are defined as the following newly diagnosed non-fatal cardiovascular events or other clinical endpoints relevant to prostate cancer survivorship: type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and osteoporotic fracture. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Race | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Arizona Oncology-Deer Valley Center | Phoenix | Arizona | 85027 | United States |
| Arizona Oncology Services Foundation | Scottsdale | Arizona | 85260 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | 95603 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| Veterans Administration Long Beach Medical Center | Long Beach | California | 90822 | United States |
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States |
| University of Southern California/Norris Cancer Center | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Rohnert Park Cancer Center | Rohnert Park | California | 94928 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | 95661 | United States |
| Sutter General Hospital | Sacramento | California | 95816 | United States |
| University of California At San Diego | San Diego | California | 92103 | United States |
| UCSF-Mount Zion | San Francisco | California | 94115 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente Cancer Treatment Center | South San Francisco | California | 94080 | United States |
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California | 95687 | United States |
| Sutter Solano Medical Center | Vallejo | California | 94589 | United States |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Poudre Valley Radiation Oncology | Fort Collins | Colorado | 80528 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| William Backus Hospital | Norwich | Connecticut | 06360 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Saint Joseph's-Candler Health System | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Idaho Urologic Institute PA | Meridian | Idaho | 83642 | United States |
| Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Hines Veterans Administration Hospital | Hines | Illinois | 60141 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Radiation Oncology Associates PC | Fort Wayne | Indiana | 46804 | United States |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kansas City Cancer Centers-Southwest | Overland Park | Kansas | 66210 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| Touro Infirmary | New Orleans | Louisiana | 70115 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Maine Medical Center- Scarborough Campus | Scarborough | Maine | 04074 | United States |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| Peninsula Regional Medical Center | Salisbury | Maryland | 21801 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Saint Anne's Hospital | Fall River | Massachusetts | 02721 | United States |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional | Milford | Massachusetts | 01757 | United States |
| North Shore Medical Center Cancer Center | Peabody | Massachusetts | 01960 | United States |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore | South Weymouth | Massachusetts | 02190 | United States |
| Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| McLaren-Flint | Flint | Michigan | 48532 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Great Lakes Cancer Institute-Lapeer Campus | Lapeer | Michigan | 48446 | United States |
| McLaren Cancer Institute-Owosso | Owosso | Michigan | 48867 | United States |
| Northern Michigan Regional Hospital | Petoskey | Michigan | 49770 | United States |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital - Troy | Troy | Michigan | 48098 | United States |
| Sanford Clinic North-Bemidgi | Bemidji | Minnesota | 56601 | United States |
| Saint Luke's Hospital of Duluth | Duluth | Minnesota | 55805 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Siteman Cancer Center - Saint Peters | City of Saint Peters | Missouri | 63376 | United States |
| Kansas City Cancer Center - South | Kansas City | Missouri | 64131 | United States |
| Kansas City Cancer Centers - North | Kansas City | Missouri | 64154 | United States |
| Kansas City Cancer Center-Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Barnes-Jewish West County Hospital | St Louis | Missouri | 63141 | United States |
| Saint John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Concord Hospital | Concord | New Hampshire | 03301 | United States |
| Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Medical Center-Fargo | Fargo | North Dakota | 58122 | United States |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Summa Barberton Hospital | Barberton | Ohio | 44203 | United States |
| Geaugra Hospital | Chardon | Ohio | 44024 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Mercy Cancer Center-Elyria | Elyria | Ohio | 44035 | United States |
| Summa Health Center at Lake Medina | Medina | Ohio | 44256 | United States |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| Southwest General Health Center Ireland Cancer Center | Middleburg Heights | Ohio | 44130 | United States |
| UHHS-Chagrin Highlands Medical Center | Orange | Ohio | 44122 | United States |
| Robinson Radiation Oncology | Ravenna | Ohio | 44266 | United States |
| Ireland Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| Flower Hospital | Sylvania | Ohio | 43560 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | United States |
| Rogue Valley Medical Center | Medford | Oregon | 97504 | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| The Regional Cancer Center | Erie | Pennsylvania | 16505 | United States |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Cherry Tree Cancer Center | Hanover | Pennsylvania | 17331 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| WellSpan Health-York Hospital | York | Pennsylvania | 17405 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Texas Oncology PA - Bedford | Bedford | Texas | 76022 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The Klabzuba Cancer Center | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555-0565 | United States |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | United States |
| Texas Cancer Center-Sherman | Sherman | Texas | 75090 | United States |
| Texas Oncology Cancer Center Sugar Land | Sugar Land | Texas | 77479 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah | 84106 | United States |
| Dixie Medical Center Regional Cancer Center | St. George | Utah | 84770 | United States |
| Sentara Cancer Institute at Sentara CarePlex Hospital | Hampton | Virginia | 23666 | United States |
| Sentara Hospitals | Norfolk | Virginia | 23507 | United States |
| Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | United States |
| Sentara Virginia Beach General Hospital | Virginia Beach | Virginia | 23454 | United States |
| Saint Francis Hospital | Federal Way | Washington | 98003 | United States |
| Virginia Mason CCOP | Seattle | Washington | 98101 | United States |
| Appleton Medical Center | Appleton | Wisconsin | 54911 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| Gundersen Lutheran | La Crosse | Wisconsin | 54601 | United States |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin | 53211 | United States |
| Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Clement J. Zablocki VA Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Wheaton Franciscan Cancer Care - All Saints | Racine | Wisconsin | 53405 | United States |
| Door County Cancer Center | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| BCCA-Cancer Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Ottawa Health Research Institute-General Division | Ottawa | Ontario | K1H 1C4 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.
| Eligible |
|
| Eligible participants who consented to Quality of Life (QOL) component |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ADT + RT | Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. |
| BG001 | TAK-700 + ADT + RT | TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Zubrod Performance Status | 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death. | Count of Participants | Participants |
| |||||||||||||||
| Gleason Score | Gleason score describes prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope. Cells are scored 1-5 with 1 indicating "low-grade" looking similar to normal cells and 5 indicating "high-grade" barely resembling normal cells due to mutation. A pathologist assigns a Gleason grade to the first and second most predominant patterns in the biopsy. The two grades are added together to calculate the Gleason score (between 2 and 10). Cancers with lower scores tend to be less aggressive, while cancers with higher scores end to be more aggressive. | Count of Participants | Participants |
| |||||||||||||||
| Study Entry PSA | Prostate-specific antigen (PSA) is a protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland, and are often used to monitor patients who have been treated for prostate cancer to see if their cancer has recurred. | Count of Participants | Participants |
| |||||||||||||||
| T-Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. | Count of Participants | Participants |
| |||||||||||||||
| Risk Factors | Count of Participants | Participants |
| ||||||||||||||||
| N-Stage N0 | Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. N0 means lymph nodes aren't involved. A higher number means the cancer is in more lymph nodes, farther away from the original tumor. NX means the lymph nodes cannot be assessed. | Count of Participants | Participants |
| |||||||||||||||
| M-Stage M0 | Metastasis stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the spread of the cancer to organs and tissues in other parts of the body. M0 = No distant metastasis; M1 = Distant metastasis; MX = Distant metastasis cannot be assessed. | Count of Participants | Participants |
| |||||||||||||||
| ADT Started Prior to Registration | Trial was amended midstudy to add this stratification variable, therefore data was not collected on all participants. | Count of Participants | Participants |
| |||||||||||||||
| RT Boost Modality | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol) | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from primary (original protocol) to secondary. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 5-year rates are provided. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Grade 3 or Higher Adverse Events | Time to grade 3 or higher adverse event (event) is defined as time from randomization to the date of first event, last known follow-up (censored), or death without failure (competing risk). Event rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Local Progression | Local recurrence (failure) is defined as biopsy proven recurrence within the prostate gland. Time to failure is defined as time from randomization to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates reported. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Distant Metastases | Distant metastases (failure) is defined as imaging or biopsy demonstrated evidence for systemic recurrence. Biopsy was not required, however it was encouraged in absence of a rising PSA. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. Note, the protocol lists this endpoint as regional or distant metastasis, but regional progression data was not collected. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With General Clinical Treatment Failure | General clinical treatment failure (GCTF) is defined as: PSA > 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of salvage androgen deprivation therapy. Failure time is defined as time from registration to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death Due to Prostate Cancer | Time to prostate cancer death is defined as time from randomization to the date of death due to prostate cancer, last known follow-up (censored), or death due to other causes (competing risk). Failure rates were to be estimated using the cumulative incidence method. If too few events occur for meaningful estimates, then only counts of events will be reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year | The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year. | Eligible participants who consented to quality of life component and had baseline and one-year data. | Posted | Mean | Standard Deviation | T-score | Baseline, one year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient-reported Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Short Form at One Year | The EPIC-Short Form is a 26-item, validated self-administered tool to assess disease-specific aspects of prostate cancer and its therapies consisting of five summary domains (bowel, urinary incontinence, urinary irritation/obstruction, sexual, and hormonal function). Responses for each item form a Likert scale which are transformed to a 0-100 scale. A domain score is the average of the transformed domain item scores, ranging from 0-100 with higher scores representing better health-related quality of life (HRQOL). Change at one year is defined as one-year value - baseline value. Positive change at one year indicates improved quality of life. | Eligible participants with data for any of the four domains. | Posted | Mean | Standard Deviation | score on a scale | Baseline, one year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Testosterone | Eligible participants with data at any of the timepoints. | Posted | Mean | Standard Deviation | ng/dL | Baseline,12 months, 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Total Cholesterol | Eligible participants with data at any of the timepoints. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 12 months, 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum High-density Lipoprotein (HDL) | Eligible participants with data at any of the timepoints. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 12 months, 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum High-density Lipoprotein (LDL) | Eligible participants with data at any of the timepoints. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 12 months, 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin A1c | Eligible participants with data at any of the timepoints. | Posted | Mean | Standard Deviation | g/dL | Baseline, 12 months, 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose | Eligible participants with data at any of the timepoints. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 12 months, 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Insulin | This data was not collected. | Posted | Mean | Standard Deviation | Baseline, 12 months, 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Mass Index (BMI) | Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). Change from baseline = time point value - baseline value. | Eligible participants data at baseline and data at any of the post-baseline timepoints. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and yearly to five years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Highest Grade Adverse Event | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data | Eligible participants who started protocol treatment | Posted | Count of Participants | Participants | From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Testosterone Recovery at 12 and 24 Months | Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Time to testosterone recovery is defined as time from randomization to the date of testosterone recovery, biochemical, local, or distant failure (competing risk), salvage therapy (competing risk), death (competing risk), or last known follow-up (censored). Testosterone recovery rates are estimated using the cumulative incidence method. | Eligible participants with testosterone data | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Testosterone Recovery Time | Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Testosterone recovery rates are estimated using the Kaplan-Meier method, censoring for biochemical, local, or distant failure, salvage therapy, death, and otherwise alive without event. Testosterone recovery time is defined as time from randomization to testosterone recovery or censoring. | Eligible participants with testosterone data | Posted | Median | 95% Confidence Interval | years | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinical Survivorship Events | Clinical survivorship events are defined as the following newly diagnosed non-fatal cardiovascular events or other clinical endpoints relevant to prostate cancer survivorship: type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and osteoporotic fracture. | Eligible participants | Posted | Count of Participants | Participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Ethnicity | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | Eligible participants. Data stratified by ethnicity. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Race | Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. | Eligible participants. Data stratified by race. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here. |
|
From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADT + RT | Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. | 24 | 115 | 19 | 112 | 108 | 112 |
| EG001 | TAK-700 + ADT + RT | TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years. | 19 | 116 | 38 | 115 | 112 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Eye disorders - Other | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Irritability | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sudden death NOS | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vascular disorders - Other | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditio | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders and administration site conditions | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vascular disorders - Other | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
This study closed to accrual early at 238 participants out of 900 planned due to discontinuation of support from the industry partner (Takeda/Millenium) for further development of TAK-700 in prostate cancer. The study endpoints and statistical considerations were revised to take the smaller sample size into account. The revised protocol contains both the original and revised statistical sections.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Sep 30, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2018 | Sep 30, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| D002064 | Buserelin |
| D017329 | Triptorelin Pamoate |
| D000726 | Androgen Antagonists |
| D005485 | Flutamide |
| C053541 | bicalutamide |
| C571806 | orteronel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D006727 | Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013812 | Therapeutics |
Not provided
Not provided
| 50 - 59 years |
|
| 60 - 69 years |
|
| ≥ 70 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|