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