A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID: NCT02499497
Run by: Dana-Farber Cancer Institute
People needed: 114
Starts: 2016-02-29
Expected to finish: 2020-10-31
Last updated by the study team: 2021-09-28

Who can join

Age: 19 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Florida — Gainesville, Florida, United States
John Hopkins Medical Center — Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center (Referring site only) — Boston, Massachusetts, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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