Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is test another form of hormonal therapy with radiation therapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide with External Beam Radiation | Experimental | Enzalutamide 40 mg orally 4x daily for 6 (28 day +/-3 days) cycles. External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide 75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks. *Patients that are unable to complete enzalutamide therapy will still be treated with EBRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug |
|
| |
| External Beam Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PSA at or Below 0.2 ng/ml | Percentage of participants with PSA level of less than or equal to 0.2 ng/ml at the end of six cycles of enzalutamide and EBRT treatment. Post-treatment PSA nadir level has been shown to be a validated intermediate cancer endpoint in similar settings. The chosen cut-off of 0.2 ng/ml was informed by D'Amico et al Lancet Oncology 2012. PSA levels determined through established methods (blood draw and serum analysis). | End of treatment, up to 27 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Median DHEA-S | Median DHEA-S, collected and assessed using established methods. Reference range is 28-640 ug/dL for adult males. | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
| Median Androstenedione |
Not provided
Inclusion Criteria:
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
Patients must NOT meet any of the following exclusion criteria
Received an investigational agent within 4 weeks prior to enrollment
Stage T4 prostate cancer by clinical examination or radiologic evaluation.
Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL below the normal range for the institution.
Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
Receiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to enrollment or having taken finasteride or dutasteride within 30 days of registration.
History of another active malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and superficial bladder cancer. Participants treated for malignancy with no relapse within two years are eligible to participate in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment.
Unwilling to use contraceptives while on study if relevant to patient.
History of seizure or any condition or concurrent medication that may predispose to seizure.
History of loss of consciousness or transient ischemic attack within 12 months prior to enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn Bubley, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33636278 | Result | Kaplan I, Bubley GJ, Bhatt RS, Taplin ME, Dowling S, Mahoney K, Werner E, Nguyen P. Enzalutamide With Radiation Therapy for Intermediate-Risk Prostate Cancer: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1416-1422. doi: 10.1016/j.ijrobp.2021.02.027. Epub 2021 Feb 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment from February 2014 to February 2017
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide With External Beam Radiation | Enzalutamide 40 mg orally 4x daily for 6 (28 day +/-3 days) cycles. External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide 75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks. *Patients that are unable to complete enzalutamide therapy will still be treated with EBRT Enzalutamide External Beam Radiation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide With External Beam Radiation | Enzalutamide 40 mg orally 4x daily for 6 (28 day +/-3 days) cycles. External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide 75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks. *Patients that are unable to complete enzalutamide therapy will still be treated with EBRT Enzalutamide External Beam Radiation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 PSA at or Below 0.2 ng/ml | Percentage of participants with PSA level of less than or equal to 0.2 ng/ml at the end of six cycles of enzalutamide and EBRT treatment. Post-treatment PSA nadir level has been shown to be a validated intermediate cancer endpoint in similar settings. The chosen cut-off of 0.2 ng/ml was informed by D'Amico et al Lancet Oncology 2012. PSA levels determined through established methods (blood draw and serum analysis). | Participants who completed treatment are included in this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, up to 27 weeks. |
|
Evaluated while on treatment and up to the 3 month follow up visit, up to 40 weeks.
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term. Participants are not being evaluated based on their post-operative treatment option.
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 | Enzalutamide With External Beam Radiation | Enzalutamide 40 mg orally 4x daily for 6 (28 day +/-3 days) cycles. External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide 75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks. *Patients that are unable to complete enzalutamide therapy will still be treated with EBRT Enzalutamide External Beam Radiation |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Bubley MD | Dana-Farber Cancer Institute | 617-735-2062 | gbubley@bidmc.harvard.edu |
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 | Jan 9, 2015 | Dec 20, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiation |
|
Median androstenedione, collected and assessed using established methods. Reference range is 40-150 ng/dL for adult males.
| Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
| Median Testosterone | Median testosterone, collected and assessed using established methods. Reference range is 300-1050 ng/dL for adult males. | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
| Median Free Testosterone | Median free testosterone, collected and assessed using established methods. Reference range is 350-1200 ng/dL for adult males. | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
| Median Estrone | Median estrone, collected and assessed using established methods. Reference range is 12-72 pg/mL for adult males. | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
| Median Estradiol | Median estradiol, collected and assessed using established methods. The reference range is 13-42 pg/mL for adult males. | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
| Median Bicep Fat Fold Measurement | Median bicep fat fold measurement taken at baseline and end of treatment. | At baseline and end of treatment, up to 27 weeks |
| Median Tricep Fat Fold Measurement | Median tricep fat fold measurement taken at baseline and end of treatment. | At baseline and end of treatment, up to 27 weeks |
| Median Shoulder Blade Fat Fold Measurement | Median shoulder blade fat fold measurement taken at baseline and end of treatment. | At baseline and end of treatment, up to 27 weeks |
| Median Waist Fat Fold Measurement | Median waist fat fold measurement taken at baseline and end of treatment. | At baseline and end of treatment, up to 27 weeks |
| Median Waist Circumference | Median waist circumference taken at baseline and end of treatment. | At baseline and end of treatment, up to 27 weeks |
| Median Weight | Median weight taken at baseline and end of treatment. | At baseline and end of treatment, up to 27 weeks |
| Number of Participants With a Sleep Quality Score of 0 or 1 | Sleep quality measure of the Pittsburgh Sleep Quality Index (PSQI) is scored from 0-3 [0=Very bad, 1=Fairly bad, 2=Fairly good, 3=Very good]. The higher the score, the better the sleep quality. | Measured at cycles 1, 3, and 5. |
| Urinary Incontinence Median Score | Urinary incontinence evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26) EPIC-26 evaluates patient's urinary incontinence (4 items). The 4 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. | Measured at cycles 1, 3, and 5. |
| Urinary Irritation Median Score | Urinary irritation evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates urinary irritation/obstruction (4 items). The final score from the 4 items is reported on a scale of 0 - 100. A higher score indicates better urinary function. | Measured at cycles 1, 3, and 5. |
| Bowel Function Median Score | Bowel function measure through the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's bowel (6 items). The 6 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. | Measured at cycles 1, 3, and 5. |
| Sexual Function Median Score | Sexual function measure through The Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's sexual function (5 items). The 5 items are reported on a scale of 0 - 100.A higher score indicates better urinary function. | Measured at cycles 1, 3, and 5. |
| Hormone Function Median Score | Hormone function evaluated by the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's hormonal function (5 items). The 5 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. | Measured at cycles 1, 3, and 5. |
| Number of Participants With a Fatigue Score of 3 or 4 | Feeling fatigue measure of the Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue Short Form is scored from 0-4 [0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much]. The higher the score, the more fatigued the patient is. | Cycles 1, 3, and 5 |
| Median Collagen Type 1 C-Telopeptide | Median Collagen Type 1 C-Telopeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 60-1200 pg/mL | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks |
| Median Bone-Specific Alkaline Phosphatase | Median Bone-Specific Alkaline Phosphatase is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 7.5-69.8 ug/L | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks |
| Median Procollagen Type II Intact N Terminal Propeptide | Median Procollagen Type II Intact N Terminal Propeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 22-87 ug/L | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| M Stage | Metastatic Stage MX: Metastasis cannot be evaluated. M0: The cancer has not metastasized beyond the immediate prostate region. M1: The cancer has metastasized deeper into the body. | Count of Participants | Participants |
|
| N Stage | Node Stage: NX: The regional lymph nodes cannot be evaluated. N0: The cancer has not spread to lymph nodes in the immediate area. N1: The cancer has spread to lymph nodes in the pelvic region. | Count of Participants | Participants |
|
| T Stage | Tumor Stage: T1a: Tumor is found accidentally during a surgical procedure used to treat benign prostatic hyperplasia (BPH). Found in 5 percent or less of the tissue removed. T1b: Found accidentally during BPH surgery. Detected in more than 5 percent of the tissue removed. T1c: Found during a needle biopsy that was performed because of elevated PSA level. T2a: Has invaded one-half (or less) of one side of the prostate. T2b: Has spread to more than one-half of one side of the prostate, but not to both sides. T2c: Has invaded both sides of the prostate. T3: Has grown outside the prostate | Count of Participants | Participants |
|
| Gleason Score | The pathologist looking at the biopsy sample will assign one Gleason grade to the most predominant pattern in your biopsy and a second Gleason grade to the second most predominant pattern. For example: 3 + 4. The two grades will then be added together to determine your Gleason score. Theoretically, Gleason scores range from 2-10. However, since Dr. Gleason's original classification, pathologists almost never assign scores 2-5, and Gleason scores assigned will range from 6 to 10, with 6 being the lowest grade cancer. | Count of Participants | Participants |
|
| Primary Gleason Score | Because numerous studies suggest that Gleason 3 + 4 tumors (ie, those where pattern 3 is most prevalent but some amount of pattern 4 is also observed) have a better prognosis than Gleason 4 + 3 tumors (ie, those where pattern 4 is more prevalent than pattern 3), contemporary clinical risk prediction now incorporates primary and secondary Gleason pattern. | Count of Participants | Participants |
|
| Baseline Prostate Specific Antigen (PSA) | Mean | Full Range | ng/mL |
|
| Risk Stratification | Men with intermediate-risk prostate cancer are subdivided into favorable and unfavorable subgroups. Intermediate risk: Tumor is confined to the prostate, the PSA=10-20, or Gleason Score=7 Favorable patients were those who had all of the following: One intermediate-risk factor (based on the NCCN classification scheme). Gleason Score of 3+4=7 or less. Less than 50% of biopsy cores positive for cancer. Those who were classified as unfavorable could have any of the following: More than one intermediate-risk factor. Gleason Score of 4+3=7. Greater than 50% positive biopsy cores. | Count of Participants | Participants |
|
|
|
| Secondary | Median DHEA-S | Median DHEA-S, collected and assessed using established methods. Reference range is 28-640 ug/dL for adult males. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | ug/dL | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Androstenedione | Median androstenedione, collected and assessed using established methods. Reference range is 40-150 ng/dL for adult males. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | ng/dL | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Testosterone | Median testosterone, collected and assessed using established methods. Reference range is 300-1050 ng/dL for adult males. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | ng/dL | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Free Testosterone | Median free testosterone, collected and assessed using established methods. Reference range is 350-1200 ng/dL for adult males. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | pg/mL | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Estrone | Median estrone, collected and assessed using established methods. Reference range is 12-72 pg/mL for adult males. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | pg/mL | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Estradiol | Median estradiol, collected and assessed using established methods. The reference range is 13-42 pg/mL for adult males. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | pg/mL | Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Bicep Fat Fold Measurement | Median bicep fat fold measurement taken at baseline and end of treatment. | The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | mm | At baseline and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Tricep Fat Fold Measurement | Median tricep fat fold measurement taken at baseline and end of treatment. | The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | mm | At baseline and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Shoulder Blade Fat Fold Measurement | Median shoulder blade fat fold measurement taken at baseline and end of treatment. | The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | mm | At baseline and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Waist Fat Fold Measurement | Median waist fat fold measurement taken at baseline and end of treatment. | The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | mm | At baseline and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Waist Circumference | Median waist circumference taken at baseline and end of treatment. | The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | mm | At baseline and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Median Weight | Median weight taken at baseline and end of treatment. | The analysis population is comprised of all patients who completed treatment with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | kg | At baseline and end of treatment, up to 27 weeks |
|
|
|
| Secondary | Number of Participants With a Sleep Quality Score of 0 or 1 | Sleep quality measure of the Pittsburgh Sleep Quality Index (PSQI) is scored from 0-3 [0=Very bad, 1=Fairly bad, 2=Fairly good, 3=Very good]. The higher the score, the better the sleep quality. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Count of Participants | Participants | Measured at cycles 1, 3, and 5. |
|
|
|
| Secondary | Urinary Incontinence Median Score | Urinary incontinence evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26) EPIC-26 evaluates patient's urinary incontinence (4 items). The 4 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | score | Measured at cycles 1, 3, and 5. |
|
|
|
| Secondary | Urinary Irritation Median Score | Urinary irritation evaluated using the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates urinary irritation/obstruction (4 items). The final score from the 4 items is reported on a scale of 0 - 100. A higher score indicates better urinary function. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | score | Measured at cycles 1, 3, and 5. |
|
|
|
| Secondary | Bowel Function Median Score | Bowel function measure through the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's bowel (6 items). The 6 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | score | Measured at cycles 1, 3, and 5. |
|
|
|
| Secondary | Sexual Function Median Score | Sexual function measure through The Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's sexual function (5 items). The 5 items are reported on a scale of 0 - 100.A higher score indicates better urinary function. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | score | Measured at cycles 1, 3, and 5. |
|
|
|
| Secondary | Hormone Function Median Score | Hormone function evaluated by the Expanded-Prostate Index Composite - 26 (EPIC 26). EPIC-26 evaluates patient's hormonal function (5 items). The 5 items are reported on a scale of 0 - 100. A higher score indicates better urinary function. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | score | Measured at cycles 1, 3, and 5. |
|
|
|
| Secondary | Number of Participants With a Fatigue Score of 3 or 4 | Feeling fatigue measure of the Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue Short Form is scored from 0-4 [0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much]. The higher the score, the more fatigued the patient is. | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Count of Participants | Participants | Cycles 1, 3, and 5 |
|
|
|
| Secondary | Median Collagen Type 1 C-Telopeptide | Median Collagen Type 1 C-Telopeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 60-1200 pg/mL | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Inter-Quartile Range | pg/mL | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks |
|
|
|
| Secondary | Median Bone-Specific Alkaline Phosphatase | Median Bone-Specific Alkaline Phosphatase is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 7.5-69.8 ug/L | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Inter-Quartile Range | ug/L | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks |
|
|
|
| Secondary | Median Procollagen Type II Intact N Terminal Propeptide | Median Procollagen Type II Intact N Terminal Propeptide is a biomarker for bone metabolism measured and analyzed using established methods. Reference range for adult males is 22-87 ug/L | The analysis population is comprised of all enrolled patients with evaluable data for this endpoint at each respective timepoint. As treatment went on, some patients dropped out and/or missed appointments and, as such, data was not collected on these patients. | Posted | Median | Full Range | ug/L | Measured at baseline, end of treatment, and at 3 month follow-up, up to 40 weeks |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 64 |
| 64 |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irritability | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Prostate infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Concentration impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
|
| End of treatment |
|
|
|
| End of treatment |
|
|
|
| End of treatment |
|
|
|
| End of treatment |
|
|
|
| End of treatment |
|
|
|
| End of treatment |
|
|
|
|
|
|
|
|
|
| Cycle 5 |
|
|
|
| Cycle 5 |
|
|
|
| Cycle 5 |
|
|
|
| Cycle 5 |
|
|
|
| Cycle 5 |
|
|
|
| Cycle 5 |
|
|
|
| Cycle 5 |
|
|
|
| 3 Month Follow-up |
|
|
|
| 3 Month Follow-up |
|
|
|
| 3 Month Follow-up |
|
|