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| ID | Type | Description | Link |
|---|---|---|---|
| STEEL | Other Identifier | RTOG Foundation |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Astellas Pharma Inc | INDUSTRY |
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Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.
PRIMARY OBJECTIVE:
To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salvage Radiation Therapy (SRT) + Standard androgen deprivation therapy (ADT) | Active Comparator | Standard ADT: 24 months of GnRH analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
|
| Salvage Radiation Therapy + Enhanced ADT | Experimental | Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | daily fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive Without Progression (Progression-Free Survival) | Progression-free survival (PFS) is estimated by the Kaplan-Meier method. PFS time is measured from randomization to the date of first PFS failure (biochemical or clinical failure, initiation of new unplanned anticancer treatment, or death from any cause) or last known follow-up (censored). Analysis was to occur after progression or death was reported for 101 participants. Biochemical failure is defined as first post-RT detectable PSA (PSA ≥ 0.05). Clinical failure is defined as either a local, regional, or distant failure. | From randomization to first failure or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biochemical Failure | Biochemical failure is defined as the first detectable post-RT prostate-specific antigen (PSA) value (≥ 0.05) or the initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis. | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
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Inclusion Criteria:
Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
Prostate-specific antigen (PSA) level (≥ 0.2 ng/mL) within 120 days prior to registration. Patients must have a PSA ≥ 0.2 ng/mL prior to starting ADT. For patients being followed by an ultrasensitive PSA assay, a serum PSA concentration of ≥ 0.10 ng/mL will be considered eligible.
GnRH analog may be started no more than 42 days prior study entry.
Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
Platelet count ≥ 75,000 x 10^9/µL independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following aggressive features:
Gleason score of 8-10 (note any Gleason score is eligible)
Seminal vesicle invasion (SVI) (note any pT stage American Joint Committee on Cancer (AJCC) v8.0 is eligible but a pT stage
≥ pT3b is considered aggressive)
Locoregional node involvement at radical prostatectomy (RP) (pN1)
Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy
PSA ≥ 0.7 ng/mL
Serum albumin ≥ 3.0 g/dL within 90 days prior to registration
Glomerular filtration rate (GFR) ≥35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration.
Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within 90 days prior to registration.
History and physical with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or within 90 days prior to registration.
Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes.
Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years).
Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable.
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
History of any of the following:
Known gastrointestinal disorder affecting absorption of oral medications.
Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed.
HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART.
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| Name | Affiliation | Role |
|---|---|---|
| Edwin Posadas, MD | RTOG Foundation | Principal Investigator |
| Hiram Gay, MD | RTOG Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Center for Cancer Care - Gilbert | Gilbert | Arizona | 85297 | United States | ||
| Arizona Center for Cancer Care - Peoria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38421243 | Derived | Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Salvage Radiation Therapy (SRT) + Standard Androgen Deprivation Therapy (ADT) | Standard ADT: 24 months of gonadotropin-releasing hormone (GnRH) analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Jul 12, 2022 |
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|
| Enzalutamide | Drug | tablet |
|
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| Bicalutamide | Drug | tablet |
|
|
| GnRH analog | Drug | Injection |
|
|
| Percentage of Participants With Alternative Biochemical Failure | Alternative biochemical failure is defined as first post-RT PSA ≥ 0.1 ng/mL or initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis. | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
| Percentage of Participants With Hormone-refractory Disease | Hormone-refractory disease is defined as three rises in PSA during salvage androgen deprivation, with the date determined as the midway date between the last non-rising PSA and the first of the three rises. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided. | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
| Percentage of Participants With Distant Metastasis | Distant failure is defined as first radiographic evidence of distant metastasis (e.g., bone scan, computed tomography (CT), magnetic resonance imaging (MRI)). Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided. | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
| Percentage of Participants With Prostate Cancer Death | Cause-specific mortality is defined as death due to prostate cancer. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided. | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
| Percentage of Participants Alive (Overall Survival) | Survival rates were to be estimated using the Kaplan-Meier method, censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only counts are provided. In this case, the number of participants without event (death), which is the number of participants alive. | From randomization to death or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
| Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement. | Baseline and end of radiation treatment (RT). End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score | The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement. | Baseline and one year after end RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score | The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement. | Baseline and two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Change From Baseline to End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Baseline and end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Baseline and one year after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Baseline, two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From randomization to death or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. |
| Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From randomization to 30 days after the end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From 31 days after the end of RT to death or last known follow-up. Median follow-up was 33.1 months. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05. | End of RT, one and two years after the end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
| Peoria |
| Arizona |
| 85381 |
| United States |
| Arizona Center for Cancer Care - Phoenix | Phoenix | Arizona | 85027 | United States |
| Arizona Center for Cancer Care - Scottsdale East | Scottsdale | Arizona | 85251 | United States |
| Arizona Center for Cancer Care - Scottsdale North | Scottsdale | Arizona | 85258 | United States |
| Arizona Center for Cancer Care - Surprise | Surprise | Arizona | 85374 | United States |
| Marin Cancer Care, Inc. | Greenbrae | California | 94904 | United States |
| Marin Health Medical Center | Greenbrae | California | 94904 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| USC Medical Center - Los Angeles County | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Roseville Radiation Oncology Center | Roseville | California | 95661 | United States |
| Sutter Roseville Medical Center | Roseville | California | 95661 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| Valley View Hospital Cancer Center | Glenwood Springs | Colorado | 81601 | United States |
| University of Florida Health Science Center | Gainesville | Florida | 32608 | United States |
| AdventHealth Orlando | Orlando | Florida | 32804 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Nancy N. & J.C. Lewis Cancer & Research Pavilion | Savannah | Georgia | 31405 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Kansas University Cancer Center Overland Park | Overland Park | Kansas | 66210 | United States |
| Kansas University Cancer Center Westwood | Westwood | Kansas | 66205 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| LSU Healthcare Network/Metairie Multi-Specialty Clinic | Metairie | Louisiana | 70006 | United States |
| Coastal Cancer Treatment Center - Bath | Bath | Maine | 04530 | United States |
| Waldo Count General Hospital - Belfast | Belfast | Maine | 04915 | United States |
| Maine Health/SMHC Cancer Care and Blood Disorders-Biddeford | Biddeford | Maine | 04005 | United States |
| Maine Health/Stephens Memorial - Norway | Norway | Maine | 04268 | United States |
| Maine Medical Center - Bramhall S Portland | Portland | Maine | 04102 | United States |
| Penobscot Bay Medical Center - Rockport | Rockport | Maine | 04856 | United States |
| Maine Health CC of York County - Sanford | Sanford | Maine | 04073 | United States |
| Maine Health/SMHCancer Care and Blood Disorders - Sanford | Sanford | Maine | 04073 | United States |
| Maine Medical Cancer Center - Scarborough Campus | Scarborough | Maine | 04074 | United States |
| Maine Medical Partners - South Portland | South Portland | Maine | 04106 | United States |
| McLaren Cancer Institute - Bloomfield | Bloomfield | Michigan | 48302 | United States |
| 21st Century Oncology MHP - Clarkston | Clarkston | Michigan | 48346 | United States |
| McLaren Cancer Institute - Clarkston | Clarkston | Michigan | 48346 | United States |
| William Beaumont Hospital - Dearborn | Dearborn | Michigan | 48124 | United States |
| Wayne State/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| 21st Century Oncology MHP - Farmington | Farmington Hills | Michigan | 48334 | United States |
| McLaren Cancer Institute - Flint | Flint | Michigan | 48532 | United States |
| Singh and Arora Hematology Oncology PC | Flint | Michigan | 48532 | United States |
| McLaren Cancer Institute - Greater Lansing | Lansing | Michigan | 48910 | United States |
| Mid-Michigan Physicians - Lansing | Lansing | Michigan | 48912 | United States |
| McLaren Cancer Institute - Lapeer Region | Lapeer | Michigan | 48446 | United States |
| 21st Century Oncology MHP - Macomb | Macomb | Michigan | 48044 | United States |
| 21st Century Oncology MHP - Madison Heights | Madison Heights | Michigan | 48071 | United States |
| McLaren Cancer Institute - Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren Cancer Institute - Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| McLaren Cancer Institute - Owosso | Owosso | Michigan | 48867 | United States |
| McLaren Cancer Institute - Northern Michigan | Petoskey | Michigan | 49770 | United States |
| McLaren Cancer Institute - Port Huron | Port Huron | Michigan | 48060 | United States |
| William Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital - Troy | Sterling Heights | Michigan | 48314 | United States |
| 21st Century Oncology MHP - Troy | Troy | Michigan | 48098 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Minnesota Oncology Hematology PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Coborn Cancer Center | Saint Cloud | Minnesota | 56303 | United States |
| HealthPartners, Inc. | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Kansas University Cancer Center North | Kansas City | Missouri | 64154 | United States |
| Kansas University Cancer Center Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| University Physicians at Oneida | Oneida | New York | 13421 | United States |
| Upstate Cancer Center Radiation Oncology at Oneida | Oneida | New York | 13421 | United States |
| University Physicians at Oswego | Oswego | New York | 13126 | United States |
| Upstate Cancer Radiation Oncology at Oswego | Oswego | New York | 13126 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Upstate Cancer Center at Hill Radiation Oncology | Syracuse | New York | 13210 | United States |
| UNC Rex Cancer Center | Raleigh | North Carolina | 27607 | United States |
| Rex Cancer Center of Wakefield | Raleigh | North Carolina | 27614 | United States |
| WellSpan Health - Ephrata Cancer Center | Ephrata | Pennsylvania | 17522 | United States |
| WellSpan Health - Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| WellSpan Health - Sechler Family Cancer Center | Lebanon | Pennsylvania | 17402 | United States |
| University of Pittsburgh Medical Center - Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| WellSpan Health - York Hospital | York | Pennsylvania | 17403 | United States |
| Gibbs Cancer Center - Pelham | Greer | South Carolina | 29650 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| UT Southwestern/Simmons Cancer Center - Dallas | Dallas | Texas | 75390 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Cedar City Hospital | Cedar City | Utah | 84721 | United States |
| Logan Regional Medical Center | Logan | Utah | 84341 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Utah Valley Regional Medical Center | Provo | Utah | 84604 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84790 | United States |
| Dartmouth Hitchcock Medical Center/Norris Cancer Ctr. - St. Johnsbury | Saint Johnsbury | Vermont | 05819 | United States |
| Sentara Cancer Institute at Sentara CarePlex Hospital | Hampton | Virginia | 23666 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Sentara Virginia Beach General Hospital | Virginia Beach | Virginia | 23454 | United States |
| Aspirus Langlade Hospital | Antigo | Wisconsin | 54409 | United States |
| University Cancer Center Johnson Creek | Johnson Creek | Wisconsin | 53038 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Froedtert Hospital & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Drexel Town Square | Oak Creek | Wisconsin | 53154 | United States |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | United States |
| Froedtert West Bend Hospital | West Bend | Wisconsin | 53095 | United States |
| Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | 54494 | United States |
| CHU de Quebec - L'Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| CIUSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | J1H 5N4 | Canada |
| FG001 | Salvage Radiation Therapy + Enhanced ADT | Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
| Adverse Event Population | Randomized participants who started treatment and were assessed for adverse events. |
|
| COMPLETED | Participants contributing data to results are considered to have completed the study. |
|
| NOT COMPLETED |
|
Randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SRT + Standard ADT | Standard ADT: 24 months of GnRH analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
| BG001 | SRT + Enhanced ADT | Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
| 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, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline 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. | Median | Full Range | ng/mL |
| ||||||||||||||
| Pathologic T-Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) 8th 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. Higher numbers and/or letters indicate worse condition. | Count of Participants | Participants |
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| Pathologic N-Stage | Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 8th 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 |
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| 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 |
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| ECOG (Eastern Cooperative Oncology Group) Performance Status Scale | 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. (Only 0 and 1 were allowed for this study.) | Count of Participants | Participants |
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| Number of aggressive features | The following are considered aggressive features:
| 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 Alive Without Progression (Progression-Free Survival) | Progression-free survival (PFS) is estimated by the Kaplan-Meier method. PFS time is measured from randomization to the date of first PFS failure (biochemical or clinical failure, initiation of new unplanned anticancer treatment, or death from any cause) or last known follow-up (censored). Analysis was to occur after progression or death was reported for 101 participants. Biochemical failure is defined as first post-RT detectable PSA (PSA ≥ 0.05). Clinical failure is defined as either a local, regional, or distant failure. | Randomized participants | Posted | Number | 80% Confidence Interval | percentage of participants | From randomization to first failure or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
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| Secondary | Percentage of Participants With Biochemical Failure | Biochemical failure is defined as the first detectable post-RT prostate-specific antigen (PSA) value (≥ 0.05) or the initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis. | Randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
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| Secondary | Percentage of Participants With Alternative Biochemical Failure | Alternative biochemical failure is defined as first post-RT PSA ≥ 0.1 ng/mL or initiation of salvage hormone therapy. Failure rates are estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis. | Randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
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| Secondary | Percentage of Participants With Hormone-refractory Disease | Hormone-refractory disease is defined as three rises in PSA during salvage androgen deprivation, with the date determined as the midway date between the last non-rising PSA and the first of the three rises. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided. | Randomized participants | Posted | Count of Participants | Participants | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
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| Secondary | Percentage of Participants With Distant Metastasis | Distant failure is defined as first radiographic evidence of distant metastasis (e.g., bone scan, computed tomography (CT), magnetic resonance imaging (MRI)). Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided. | Randomized participants | Posted | Count of Participants | Participants | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
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| Secondary | Percentage of Participants With Prostate Cancer Death | Cause-specific mortality is defined as death due to prostate cancer. Failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only the counts of participants with the event are provided. | Randomized participants | Posted | Count of Participants | Participants | From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
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| Secondary | Percentage of Participants Alive (Overall Survival) | Survival rates were to be estimated using the Kaplan-Meier method, censoring participants alive at time of analysis, but for endpoints with < 10 events overall, such as this one, only counts are provided. In this case, the number of participants without event (death), which is the number of participants alive. | Randomized participants | Posted | Count of Participants | Participants | From randomization to death or last known follow-up, whichever occurs first. Median follow-up time at the time of analysis was 33.1 months. |
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| Secondary | Change From Baseline to End of RT in the 5-level European Quality of Life Questionnaire (EQ-5D-5L) Index Score | The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement. | Randomized participants who consented to the quality of life study component and who have baseline and end of RT data | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of radiation treatment (RT). End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Change From Baseline to One Year After End of RT in the EQ-5D-5L Index Score | The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement. | Randomized participants who consented to the quality of life study component and who have baseline and one year after end of RT data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and one year after end RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Change From Baseline to Two Years After End of RT in the EQ-5D-5L Index Score | The EQ-5D-5L is a self-assessment questionnaire. The index score is computed from 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change score was calculated by subtracting baseline from later score, with a positive change score indicating improvement. | Randomized participants who consented to the quality of life study component and who have baseline and two year after end of RT data | Posted | Mean | Standard Deviation | score on a scale | Baseline and two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Change From Baseline to End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Randomized participants who consented to the quality of life study component and who have baseline and end of RT data | Posted | Mean | Standard Deviation | score on a scale | Baseline and end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Change From Baseline to One Year After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Randomized participants who consented to the quality of life study component and who have baseline and end of RT data | Posted | Mean | Standard Deviation | score on a scale | Baseline and one year after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Change From Baseline to Two Years After the End of RT in the 7-item Patient Reported Outcomes Measurement Information System - Fatigue Short Form (PROMIS-F SF 7a) [PROMIS Fatigue Score] | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Randomized participants who consented to the quality-of-life study component and who have baseline and two years after end of RT data | Posted | Mean | Standard Deviation | score on a scale | Baseline, two years after end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Number of Participants by Highest Grade Adverse Event Reported CTCAE v5 | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Randomized participants who started protocol treatment and were assessed for adverse events. | Posted | Count of Participants | Participants | From randomization to death or last known follow-up. Median follow-up time at the time of analysis was 33.1 months. |
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| Secondary | Number of Participants Any Adverse Event Occuring Within 30 Days Following the End of Treatment | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Randomized participants who started protocol treatment and were assessed for adverse events. | Posted | Count of Participants | Participants | From randomization to 30 days after the end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Number of Participants With Any Grade 3+ Adverse Event Occuring After 30 Days Following the End of RT | Common Terminology Criteria for Adverse Events (version 5) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Randomized participants who started protocol treatment, were assessed for adverse events, and alive 30 days after radiation therapy ended. | Posted | Count of Participants | Participants | From 31 days after the end of RT to death or last known follow-up. Median follow-up was 33.1 months. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Secondary | Number of Participants With Post-baseline Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores ≥ 3 | PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values < 0.05. | Randomized participants with PRO-CTCAE data. | Posted | Count of Participants | Participants | End of RT, one and two years after the end of RT. End of RT can vary greatly depending on when it starts, which can be from 0 to 70 days from the start of ADT, and lasting 7-8 weeks. |
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| Post-Hoc | Percentage of Participants Alive Without Progression (Progression-Free Survival) [Alternate Definition] | Progression-free survival (PFS) is estimated by the Kaplan-Meier method. PFS time is measured from randomization to the date of first PFS failure (biochemical or clinical failure, initiation of new unplanned anticancer treatment, or death from any cause) or last known follow-up (censored). Analysis was to occur after progression or death was reported for 101 participants. Biochemical failure is defined as first post-RT PSA ≥ 0.2. Clinical failure is defined as either a local, regional, or distant failure. | Randomized participants | Posted | Number | 80% Confidence Interval | percentage of participants | From randomization to first failure or last known follow-up. Medium follow-up time at the time of analysis was 33.1 months. The 1- and 2-year estimates are reported. |
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Baseline to the date of last known follow-up. Maximum follow-up time was 40.1 months.
All-cause mortality was assessed in randomized participants. Adverse events were assessed in randomized participants who started protocol treatment and were assessed for adverse events.
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 | SRT + Standard ADT | Standard ADT: 24 months of GnRH analog (any formulation) with optional 1-4 months of bicalutamide (50 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. | 2 | 98 | 11 | 98 | 89 | 98 |
| EG001 | SRT + Enhanced ADT | Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. | 0 | 90 | 17 | 89 | 87 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Eye disorders - Other | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Colonic hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Facial pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Salivary gland infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
The sample size calculation was modified due to a change in eligibility, however the sample size itself remained the same at 242 patients since the hazard ratio was reduced of 0.65 to 0.63. Later, a change in the definition of biochemical failure which is a component of the primary endpoint of PFS decreased the sample size to 170 patients.
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 | American College of Radiology | 2155743208 | wseiferheld@acr.org |
| Feb 2, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2022 | Feb 2, 2024 | ICF_001.pdf |
Not provided
| 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 |
|---|---|
| D011878 | Radiotherapy |
| D061089 | Radiotherapy, Image-Guided |
| C540278 | enzalutamide |
| C053541 | bicalutamide |
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| C493311 | luprolide acetate gel depot |
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| T3 |
|
| T3a |
|
| T3b |
|
| T4 |
|
| N1 |
|
| NX |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| 1 |
|
| > 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| SRT + Enhanced ADT |
Enhanced ADT: 24 months of GnRH analog (any formulation) with 24 months of enzalutamide (160 mg/day). SRT: Starting within 0-70 days of initiation of GnRH analog, 66.6-70.2 Gy as 1.8 Gy/fraction in 37-39 fractions or 66.0-70.0 Gy as 2.0 Gy/fraction in 33-35 fractions lasting approximately 7-8 weeks, and optional lymph node boost. |
|
|
|
|
|
|