Back to resultsA Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY2452473
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer
Eligibility Criteria
Inclusion Criteria
- Age 19 years of age or older
History of prostate cancer
- Stage pathological tumor-2 (pT2) N0, M0 lesions (If American Joint Committee on Cancer (AJCC) staging is not available in medical records, the investigators will infer the staging based on extensive review of the pathology report)
- Combined Gleason score < 7 (3+4)
- Radical prostatectomy two or more years ago
- Preoperative prostate-specific antigen (PSA)<10 ng/ml (if pre-operative PSA is not available in medical records, low-risk subjects with a Gleason score of 6(3+3) and who are at least 5 years out of surgery will be considered for enrollment)
- PSA <0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL for at least two years after radical prostatectomy
Serum testosterone, measured by Liquid chromatography-tandem mass spectrometry (LC-MS/MS), <300 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL.
* Derogatis Index of Sexual Function Male II (DISF-M-II) score ≤20, fatigue (FACIT-F score <30), or physical dysfunction (self-reported difficulty in walking a 1/4 mile or climbing two flights of stairs, short physical performance battery score 4 to 9).
Ability to understand and the willingness to sign a written informed consent document.
- Agree to use adequate contraception prior to receiving the study drug, for the duration of study participation, and 4 months after completion of LY SARM administration.
Exclusion Criteria
- History of radiation monotherapy
- History of androgen deprivation therapy
- Use of testosterone, dehydroepiandrosterone (DHEA), estrogens, gonadotropin-releasing hormone (GnRH) analogs, antiandrogens, spironolactone, ketoconazole, recombinant human growth hormone (rhGH), or megestrol acetate within the past 6 months
- Use of prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks within the past 6 months
- Use of Clarithromycin, telithromycin, chloramphenicol, itraconazole, nefazodone, cobicistat within the past 6 months
- Use of penile implants, vacuum pump devices, intra-cavernosal injections
- Hematocrit >50%
- Serum creatinine >2.5 mg/dL
- Aspartate aminotransferase (AST) greater than 3x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) greater than 3x ULN
- Hemoglobin A1c >7.5%
- Body mass index (BMI) >40 kg/m2
- Diabetes requiring insulin therapy
- Severe untreated sleep apnea (treatment is defined as therapy with continuous positive airway pressure (CPAP), BiPAP, adaptive servo-ventilation (ASV), or other positive air pressure device)
- Uncontrolled heart failure (NYHA class 3 or 4)
- History of HIV
- Myocardial infarction within the last 3 months
- Acute coronary syndrome within the last 3 months
- Revascularization surgery within the last 3 months
- Stroke within the last 3 months
- Diagnosed schizophrenia or bipolar disorder or untreated depression
- Not appropriate for study based on physician discretion
Sites / Locations
- University of Florida
- John Hopkins Medical Center
- Beth Israel Deaconess Medical Center (Referring site only)
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
LY2452473 Dose 1
LY2452473 Dose 2
LY2452473 Dose 3
Arm Description
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1 or LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Outcomes
Primary Outcome Measures
Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.
Secondary Outcome Measures
Change in All Domains of International Index of Erectile Function (IIEF)
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Change in Sexual Activity, Interest, and Desire Scale (SAID)
The Sexual Activity, Interest, and Desire Scale (SAID) is an 8-item questionnaire that evaluates 3 response domains, including sexual thinking, sexual arousal, and sexual activity. The score was linearly transformed to a 0 to 100 scale for each item. The average score ranges 0-100. The higher the score, the better the sexual function.
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Derogatis Index of Sexual Function Male II (DISF-M-II) is a 25-item questionnaire that provides an estimate of perceived quality of sexual activities in 5 response domains: sexual desire/drive (range 0-33), sexual arousal (range 0-33), sexual activity (range 0-35), orgasm (range 0-26), and sexual satisfaction/partner relationship (range 0-25). The total possible score (sum of 5 domains) range of 0 to 152 with higher scores representing better function.
Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Men's Sexual Health Questionnaire (MSHQ), a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). Erection, Ejaculation and Satisfaction domains were measured and the higher score representing better sexual function and satisfaction.
Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
Expanded Prostate Cancer Index Composite (EPIC) is a 50-item, comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Of its four domains, the sexual domain (range 0-100) and hormonal domain (range 0-100) were utilized. The response for each item is standardized to a 0 to 100 scale. Higher score yields better quality of life.
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Change in Hypogonadism Energy Diary (HED)
Hypogonadism Energy Diary (HED) is a 4-item questionnaire that intended to assess real-time energy levels. Score ranges 0 to100 with higher scores representing higher energy. each question uses an 11-point numerical rating scale (0-10) with 10 corresponding to full of energy or extreme tiredness. HED score was the average of the scores for these 4 items. Scores were linearly transformed to a 0 to 100 scale. Higher scores representing higher energy.
Change in International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) is a 8-item, extensively validated and widely used self-reported measure of lower urinary tract symptoms questionnaire. It includes Urinary Symptoms (item1-7, range 0-35) and Quality of Life Due to Urinary Symptoms (item 8, range 0-6). The higher the score, the severer of the urinary symptoms and worse quality of life due to symptoms.
Change in Positive and Negative Affect Scale (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Score ranges 10-50 for both positive and negative affect. The higher scores represent higher levels of positive/negative affect.
Change in Body Mass Using DXA
Whole body, appendicular, and trunk lean mass were measured using dual energy X- ray absorptiometry (DXA), calibrated using a soft tissue phantom before each scan.
Change of Maximal Voluntary Muscle Strength
The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method
Change in Gait Speed in 6-minute Walk
Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
Change of 50 Meters Walk Tests- Unloaded /Loaded
Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. One test consisted of walking 50 meters as rapidly as possible without running (unloaded) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags(loaded). Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Change in Power of Stair Climbing Tests- Unloaded/Loaded
Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.
Change in Serum Total Testosterone Level
Serum total testosterone levels during screening was measured in the Quest Diagnostics Laboratory, Chantilly, VA, using liquid chromatography tandem mass spectrometry (LC-MS/MS) method certified by the Hormone Standardization Program for Testosterone (HoST) of the Centers for Disease Control and Prevention, Atlanta, Georgia.
Change in Free Testosterone Level
Free testosterone level for screening was measured using an equilibrium dialysis method.
Change in Serum Sex Hormone-binding Globulin (SHBG) Level
Serum SHBG level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 2.5 nmol/L, and coefficients of variation less than 10% in low, medium and high range
Change in Serum Luteinizing Hormone (LH) Level
Serum LH level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 0.1 U/L, and coefficients of variation less than 10% in low, medium and high range
Change in Estradiol Levels
Estradiol level was measured by LC-MS/MS.
Change of White Blood Cell
White Blood Cell was measured for safety monitoring.
Change of Red Blood Cell
Red Blood Cell was measured for safety monitoring.
Change in Hematocrit
Hematocrit was measured for safety monitoring.
Change in Hemoglobin
Hemoglobin was measured for safety monitoring.
Change of Mean Corpuscular Volume (MCV)
Mean corpuscular volume was measured for safety monitoring.
Change of Red Blood Cell Distribution Width (RDW)
Red blood cell distribution width (RDW) was measured for safety monitoring. RDW was calculated with: standard deviation of the mean cell size divided by the mean corpuscular volume of the red cells multiplied by 100
Change in Platelet Count
Platelet count was measured for safety monitoring.
Change of Aspartate Aminotransferase (AST)
Aspartate aminotransferase was measured for safety monitoring.
Change of Alanine Aminotransferase (ALT)
Alanine aminotransferase was measured for safety monitoring.
Change of Total Bilirubin
Total Bilirubin was measured for safety monitoring.
Change in Serum Alkaline Phosphatase
Serum alkaline phosphatase was measured for safety monitoring.
Change of Lipid Panel
Plasma lipids were measured for safety monitoring.
Change in Fasting Glucose Levels
Glucose will be measured in a fasting serum sample at Quest Lab.
Change in Insulin
Insulin will be measured using an immunoassay at Quest lab.
Full Information
NCT ID
NCT02499497
First Posted
July 6, 2015
Last Updated
September 27, 2021
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT02499497
Brief Title
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Official Title
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 29, 2016 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research study is studying the use of a targeted therapy called LY SARM, which is an investigational drug from a new class of molecules called Selective Androgen Receptor Modulators (SARMs) as a possible improvement in quality of life for participants who have undergone radical prostatectomy. Androgens are a group of hormones that play a role in male traits and reproductive activity.
The names of the study interventions involved in this study are:
- LY2452473
Detailed Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved LY SARM/LY2452473 as a treatment for any disease.
In this research study, the investigators are studying a new investigational drug called LY SARM (LY2452473). Concerns about the potential adverse effects of testosterone on the prostate have led to the development of molecules called SARMs (Selective Androgen Receptor Modulators). This investigational drug may improve sexual function, quality of life, muscle and bone mass in men with prostate cancer. This molecule was chosen because there is some evidence that shows it may help to improve sexual function and aid in the improvement of muscle mass while not having any influence on the prostate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Arm Title
LY2452473 Dose 1
Arm Type
Active Comparator
Arm Description
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Arm Title
LY2452473 Dose 2
Arm Type
Active Comparator
Arm Description
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1 or LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Arm Title
LY2452473 Dose 3
Arm Type
Active Comparator
Arm Description
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
Intervention Type
Drug
Intervention Name(s)
LY2452473
Other Intervention Name(s)
Selective Androgen Receptor Modulator
Intervention Description
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive comparator
Intervention Description
The participants will receive pills containing no active drug.
Primary Outcome Measure Information:
Title
Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
Description
The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.
Time Frame
12 weeks from baseline
Secondary Outcome Measure Information:
Title
Change in All Domains of International Index of Erectile Function (IIEF)
Description
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Time Frame
12 weeks from baseline
Title
Change in Sexual Activity, Interest, and Desire Scale (SAID)
Description
The Sexual Activity, Interest, and Desire Scale (SAID) is an 8-item questionnaire that evaluates 3 response domains, including sexual thinking, sexual arousal, and sexual activity. The score was linearly transformed to a 0 to 100 scale for each item. The average score ranges 0-100. The higher the score, the better the sexual function.
Time Frame
12 weeks from baseline
Title
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Description
Derogatis Index of Sexual Function Male II (DISF-M-II) is a 25-item questionnaire that provides an estimate of perceived quality of sexual activities in 5 response domains: sexual desire/drive (range 0-33), sexual arousal (range 0-33), sexual activity (range 0-35), orgasm (range 0-26), and sexual satisfaction/partner relationship (range 0-25). The total possible score (sum of 5 domains) range of 0 to 152 with higher scores representing better function.
Time Frame
12 weeks from baseline
Title
Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Description
Men's Sexual Health Questionnaire (MSHQ), a 25-item questionnaire, assesses sexual function and satisfaction. It consists 5 domains: Erection (3 items, ranging from 0 to 15 (best)), Ejaculation (7 items, ranging from 1 to 35 (best)), Satisfaction (6 items, ranging from 6 to 30 (best)), Sexual desire (4 items, ranging 4-20 (best)), and Sexual activity (3 items, ranging 3-15 (best)). Erection, Ejaculation and Satisfaction domains were measured and the higher score representing better sexual function and satisfaction.
Time Frame
12 weeks from baseline
Title
Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
Description
Expanded Prostate Cancer Index Composite (EPIC) is a 50-item, comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Of its four domains, the sexual domain (range 0-100) and hormonal domain (range 0-100) were utilized. The response for each item is standardized to a 0 to 100 scale. Higher score yields better quality of life.
Time Frame
12 weeks from baseline
Title
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Description
The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Time Frame
12 weeks from baseline
Title
Change in Hypogonadism Energy Diary (HED)
Description
Hypogonadism Energy Diary (HED) is a 4-item questionnaire that intended to assess real-time energy levels. Score ranges 0 to100 with higher scores representing higher energy. each question uses an 11-point numerical rating scale (0-10) with 10 corresponding to full of energy or extreme tiredness. HED score was the average of the scores for these 4 items. Scores were linearly transformed to a 0 to 100 scale. Higher scores representing higher energy.
Time Frame
12 weeks from baseline
Title
Change in International Prostate Symptom Score (IPSS)
Description
International Prostate Symptom Score (IPSS) is a 8-item, extensively validated and widely used self-reported measure of lower urinary tract symptoms questionnaire. It includes Urinary Symptoms (item1-7, range 0-35) and Quality of Life Due to Urinary Symptoms (item 8, range 0-6). The higher the score, the severer of the urinary symptoms and worse quality of life due to symptoms.
Time Frame
12 weeks from baseline
Title
Change in Positive and Negative Affect Scale (PANAS)
Description
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Score ranges 10-50 for both positive and negative affect. The higher scores represent higher levels of positive/negative affect.
Time Frame
12 weeks from baseline
Title
Change in Body Mass Using DXA
Description
Whole body, appendicular, and trunk lean mass were measured using dual energy X- ray absorptiometry (DXA), calibrated using a soft tissue phantom before each scan.
Time Frame
12 weeks from baseline
Title
Change of Maximal Voluntary Muscle Strength
Description
The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method
Time Frame
12 weeks from baseline
Title
Change in Gait Speed in 6-minute Walk
Description
Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
Time Frame
12 weeks from baseline
Title
Change of 50 Meters Walk Tests- Unloaded /Loaded
Description
Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. One test consisted of walking 50 meters as rapidly as possible without running (unloaded) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags(loaded). Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Time Frame
12 weeks from baseline
Title
Change in Power of Stair Climbing Tests- Unloaded/Loaded
Description
Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12.
Time Frame
12 weeks from baseline
Title
Change in Serum Total Testosterone Level
Description
Serum total testosterone levels during screening was measured in the Quest Diagnostics Laboratory, Chantilly, VA, using liquid chromatography tandem mass spectrometry (LC-MS/MS) method certified by the Hormone Standardization Program for Testosterone (HoST) of the Centers for Disease Control and Prevention, Atlanta, Georgia.
Time Frame
12 weeks from baseline
Title
Change in Free Testosterone Level
Description
Free testosterone level for screening was measured using an equilibrium dialysis method.
Time Frame
12 weeks from baseline
Title
Change in Serum Sex Hormone-binding Globulin (SHBG) Level
Description
Serum SHBG level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 2.5 nmol/L, and coefficients of variation less than 10% in low, medium and high range
Time Frame
12 weeks from baseline
Title
Change in Serum Luteinizing Hormone (LH) Level
Description
Serum LH level was measured using two-site directed immuno-chemiluminescence assays with sensitivity 0.1 U/L, and coefficients of variation less than 10% in low, medium and high range
Time Frame
12 weeks from baseline
Title
Change in Estradiol Levels
Description
Estradiol level was measured by LC-MS/MS.
Time Frame
12 weeks from baseline
Title
Change of White Blood Cell
Description
White Blood Cell was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Red Blood Cell
Description
Red Blood Cell was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change in Hematocrit
Description
Hematocrit was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change in Hemoglobin
Description
Hemoglobin was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Mean Corpuscular Volume (MCV)
Description
Mean corpuscular volume was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Red Blood Cell Distribution Width (RDW)
Description
Red blood cell distribution width (RDW) was measured for safety monitoring. RDW was calculated with: standard deviation of the mean cell size divided by the mean corpuscular volume of the red cells multiplied by 100
Time Frame
12 weeks from baseline
Title
Change in Platelet Count
Description
Platelet count was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Aspartate Aminotransferase (AST)
Description
Aspartate aminotransferase was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Alanine Aminotransferase (ALT)
Description
Alanine aminotransferase was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Total Bilirubin
Description
Total Bilirubin was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change in Serum Alkaline Phosphatase
Description
Serum alkaline phosphatase was measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change of Lipid Panel
Description
Plasma lipids were measured for safety monitoring.
Time Frame
12 weeks from baseline
Title
Change in Fasting Glucose Levels
Description
Glucose will be measured in a fasting serum sample at Quest Lab.
Time Frame
12 weeks from baseline
Title
Change in Insulin
Description
Insulin will be measured using an immunoassay at Quest lab.
Time Frame
12 weeks from baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age 19 years of age or older
History of prostate cancer
Stage pathological tumor-2 (pT2) N0, M0 lesions (If American Joint Committee on Cancer (AJCC) staging is not available in medical records, the investigators will infer the staging based on extensive review of the pathology report)
Combined Gleason score < 7 (3+4)
Radical prostatectomy two or more years ago
Preoperative prostate-specific antigen (PSA)<10 ng/ml (if pre-operative PSA is not available in medical records, low-risk subjects with a Gleason score of 6(3+3) and who are at least 5 years out of surgery will be considered for enrollment)
PSA <0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL for at least two years after radical prostatectomy
Serum testosterone, measured by Liquid chromatography-tandem mass spectrometry (LC-MS/MS), <300 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL.
* Derogatis Index of Sexual Function Male II (DISF-M-II) score ≤20, fatigue (FACIT-F score <30), or physical dysfunction (self-reported difficulty in walking a 1/4 mile or climbing two flights of stairs, short physical performance battery score 4 to 9).
Ability to understand and the willingness to sign a written informed consent document.
Agree to use adequate contraception prior to receiving the study drug, for the duration of study participation, and 4 months after completion of LY SARM administration.
Exclusion Criteria
History of radiation monotherapy
History of androgen deprivation therapy
Use of testosterone, dehydroepiandrosterone (DHEA), estrogens, gonadotropin-releasing hormone (GnRH) analogs, antiandrogens, spironolactone, ketoconazole, recombinant human growth hormone (rhGH), or megestrol acetate within the past 6 months
Use of prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks within the past 6 months
Use of Clarithromycin, telithromycin, chloramphenicol, itraconazole, nefazodone, cobicistat within the past 6 months
Use of penile implants, vacuum pump devices, intra-cavernosal injections
Hematocrit >50%
Serum creatinine >2.5 mg/dL
Aspartate aminotransferase (AST) greater than 3x upper limit of normal (ULN)
Alanine aminotransferase (ALT) greater than 3x ULN
Hemoglobin A1c >7.5%
Body mass index (BMI) >40 kg/m2
Diabetes requiring insulin therapy
Severe untreated sleep apnea (treatment is defined as therapy with continuous positive airway pressure (CPAP), BiPAP, adaptive servo-ventilation (ASV), or other positive air pressure device)
Uncontrolled heart failure (NYHA class 3 or 4)
History of HIV
Myocardial infarction within the last 3 months
Acute coronary syndrome within the last 3 months
Revascularization surgery within the last 3 months
Stroke within the last 3 months
Diagnosed schizophrenia or bipolar disorder or untreated depression
Not appropriate for study based on physician discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalender Bhasin, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
John Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Referring site only)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34019661
Citation
Pencina KM, Burnett AL, Storer TW, Guo W, Li Z, Kibel AS, Huang G, Blouin M, Berry DL, Basaria S, Bhasin S. A Selective Androgen Receptor Modulator (OPK-88004) in Prostate Cancer Survivors: A Randomized Trial. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2171-2186. doi: 10.1210/clinem/dgab361.
Results Reference
derived
Learn more about this trial
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
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