A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

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