Prostate CancerPhase 2NCT02499497
A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
A Phase 2 study testing LY2452473 in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- LY2452473
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Feb 2016to 31 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
John Hopkins Medical Center
Baltimore, Maryland, 21231
Beth Israel Deaconess Medical Center (Referring site only)
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Florida
Gainesville, Florida, 32611
About this study
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
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- LY2452473, Placebo
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2452473Drug
Also called Selective Androgen Receptor Modulator
LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
PlaceboDrug
Also called Inactive comparator
The participants will receive pills containing no active drug.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| LY2452473 Dose 1 | Active comparator | 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. Receives: Drug: LY2452473 |
| LY2452473 Dose 2 | Active comparator | 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. Receives: Drug: LY2452473 |
| LY2452473 Dose 3 | Active comparator | 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. Receives: Drug: LY2452473 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from baseline
Secondary outcomes (33)
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
Change of Maximal Voluntary Muscle Strength
The maximal voluntary muscle strength was measured in the leg press exercise using the 1-repetition method
Measured: 12 weeks from baseline
Change in Gait Speed in 6-minute Walk
Tests of Physical Function and Task-Specific Performance measured by gait speed in 6-min walk
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
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.
Measured: 12 weeks from baseline
Change in Free Testosterone Level
Free testosterone level for screening was measured using an equilibrium dialysis method.
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
Change in Estradiol Levels
Estradiol level was measured by LC-MS/MS.
Measured: 12 weeks from baseline
Change of White Blood Cell
White Blood Cell was measured for safety monitoring.
Measured: 12 weeks from baseline
Change of Red Blood Cell
Red Blood Cell was measured for safety monitoring.
Measured: 12 weeks from baseline
Change in Hematocrit
Hematocrit was measured for safety monitoring.
Measured: 12 weeks from baseline
Change in Hemoglobin
Hemoglobin was measured for safety monitoring.
Measured: 12 weeks from baseline
Change of Mean Corpuscular Volume (MCV)
Mean corpuscular volume was measured for safety monitoring.
Measured: 12 weeks from baseline
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
Measured: 12 weeks from baseline
Change in Platelet Count
Platelet count was measured for safety monitoring.
Measured: 12 weeks from baseline
Change of Aspartate Aminotransferase (AST)
Aspartate aminotransferase was measured for safety monitoring.
Measured: 12 weeks from baseline
Change of Alanine Aminotransferase (ALT)
Alanine aminotransferase was measured for safety monitoring.
Measured: 12 weeks from baseline
Change of Total Bilirubin
Total Bilirubin was measured for safety monitoring.
Measured: 12 weeks from baseline
Change in Serum Alkaline Phosphatase
Serum alkaline phosphatase was measured for safety monitoring.
Measured: 12 weeks from baseline
Change of Lipid Panel
Plasma lipids were measured for safety monitoring.
Measured: 12 weeks from baseline
Change in Fasting Glucose Levels
Glucose will be measured in a fasting serum sample at Quest Lab.
Measured: 12 weeks from baseline
Change in Insulin
Insulin will be measured using an immunoassay at Quest lab.
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start29 Feb 2016
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Shalender Bhasin, MD, Dana-Farber Cancer Institute
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499497
- Sponsor's protocol ID
- 15-120
- Status last verified
- Sep 2021
- First submitted
- 6 Jul 2015
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34019661
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
- ClinicalTrials.gov ID
- NCT02499497
- Acronym / sponsor ID
- 15-120
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 28 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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 | Active comparator | Drug: LY2452473Subjects 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 | Active comparator | Drug: LY2452473Subjects 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 | Active comparator | Drug: LY2452473Subjects 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 19 years of age or older
- History of prostate cancer
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2452473Also: Selective Androgen Receptor ModulatorLY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate. | Drug | LY2452473 Dose 1, LY2452473 Dose 2, LY2452473 Dose 3 |
| PlaceboAlso: Inactive comparatorThe participants will receive pills containing no active drug. | Drug | Placebo |
Primary outcome
Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
Time frame: 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.
33 secondary outcomes
Change in All Domains of International Index of Erectile Function (IIEF)
Time frame: 12 weeks from baseline
Change in Sexual Activity, Interest, and Desire Scale (SAID)
Time frame: 12 weeks from baseline
Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
Time frame: 12 weeks from baseline
Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
Time frame: 12 weeks from baseline
Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 12 weeks from baseline
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: 12 weeks from baseline
Change in Hypogonadism Energy Diary (HED)
Time frame: 12 weeks from baseline
Change in International Prostate Symptom Score (IPSS)
Time frame: 12 weeks from baseline
Change in Positive and Negative Affect Scale (PANAS)
Time frame: 12 weeks from baseline
Change in Body Mass Using DXA
Time frame: 12 weeks from baseline
Change of Maximal Voluntary Muscle Strength
Time frame: 12 weeks from baseline
Change in Gait Speed in 6-minute Walk
Time frame: 12 weeks from baseline
Change of 50 Meters Walk Tests- Unloaded /Loaded
Time frame: 12 weeks from baseline
Change in Power of Stair Climbing Tests- Unloaded/Loaded
Time frame: 12 weeks from baseline
Change in Serum Total Testosterone Level
Time frame: 12 weeks from baseline
Change in Free Testosterone Level
Time frame: 12 weeks from baseline
Change in Serum Sex Hormone-binding Globulin (SHBG) Level
Time frame: 12 weeks from baseline
Change in Serum Luteinizing Hormone (LH) Level
Time frame: 12 weeks from baseline
Change in Estradiol Levels
Time frame: 12 weeks from baseline
Change of White Blood Cell
Time frame: 12 weeks from baseline
Change of Red Blood Cell
Time frame: 12 weeks from baseline
Change in Hematocrit
Time frame: 12 weeks from baseline
Change in Hemoglobin
Time frame: 12 weeks from baseline
Change of Mean Corpuscular Volume (MCV)
Time frame: 12 weeks from baseline
Change of Red Blood Cell Distribution Width (RDW)
Time frame: 12 weeks from baseline
Change in Platelet Count
Time frame: 12 weeks from baseline
Change of Aspartate Aminotransferase (AST)
Time frame: 12 weeks from baseline
Change of Alanine Aminotransferase (ALT)
Time frame: 12 weeks from baseline
Change of Total Bilirubin
Time frame: 12 weeks from baseline
Change in Serum Alkaline Phosphatase
Time frame: 12 weeks from baseline
Change of Lipid Panel
Time frame: 12 weeks from baseline
Change in Fasting Glucose Levels
Time frame: 12 weeks from baseline
Change in Insulin
Time frame: 12 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34019661Pencina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2452473 in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4) (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.