A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: PlaceboDrug: LY2452473
- Registration Number
- NCT02499497
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. LY2452473 Dose 1 LY2452473 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. LY2452473 Dose 2 LY2452473 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. LY2452473 Dose 3 LY2452473 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.
- Primary Outcome Measures
Name Time Method Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) 12 weeks from baseline 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
Name Time Method Change in All Domains of International Index of Erectile Function (IIEF) 12 weeks from baseline 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 Derogatis Index of Sexual Function Male II (DISF-M-II) 12 weeks from baseline 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 Serum Sex Hormone-binding Globulin (SHBG) Level 12 weeks from baseline 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 12 weeks from baseline 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 12 weeks from baseline Estradiol level was measured by LC-MS/MS.
Change of White Blood Cell 12 weeks from baseline White Blood Cell was measured for safety monitoring.
Change of Red Blood Cell 12 weeks from baseline Red Blood Cell was measured for safety monitoring.
Change in Hematocrit 12 weeks from baseline Hematocrit was measured for safety monitoring.
Change in Sexual Activity, Interest, and Desire Scale (SAID) 12 weeks from baseline 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 Three Domains of Men's Sexual Health Questionnaire (MSHQ) 12 weeks from baseline 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) 12 weeks from baseline 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 12 weeks from baseline 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) 12 weeks from baseline 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) 12 weeks from baseline 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) 12 weeks from baseline 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 12 weeks from baseline 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 12 weeks from baseline 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 12 weeks from baseline Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
Change of 50 Meters Walk Tests- Unloaded /Loaded 12 weeks from baseline 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 12 weeks from baseline 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 12 weeks from baseline 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 12 weeks from baseline Free testosterone level for screening was measured using an equilibrium dialysis method.
Change of Mean Corpuscular Volume (MCV) 12 weeks from baseline Mean corpuscular volume was measured for safety monitoring.
Change in Hemoglobin 12 weeks from baseline Hemoglobin was measured for safety monitoring.
Change of Red Blood Cell Distribution Width (RDW) 12 weeks from baseline 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 12 weeks from baseline Platelet count was measured for safety monitoring.
Change of Aspartate Aminotransferase (AST) 12 weeks from baseline Aspartate aminotransferase was measured for safety monitoring.
Change of Alanine Aminotransferase (ALT) 12 weeks from baseline Alanine aminotransferase was measured for safety monitoring.
Change of Total Bilirubin 12 weeks from baseline Total Bilirubin was measured for safety monitoring.
Change in Serum Alkaline Phosphatase 12 weeks from baseline Serum alkaline phosphatase was measured for safety monitoring.
Change of Lipid Panel 12 weeks from baseline Plasma lipids were measured for safety monitoring.
Change in Fasting Glucose Levels 12 weeks from baseline Glucose will be measured in a fasting serum sample at Quest Lab.
Change in Insulin 12 weeks from baseline Insulin will be measured using an immunoassay at Quest lab.
Trial Locations
- Locations (4)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
John Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center (Referring site only)
🇺🇸Boston, Massachusetts, United States
University of Florida
🇺🇸Gainesville, Florida, United States