A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

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.

Inclusion Criteria

- Age 19 years of age or older

- History of prostate cancer

- Stage pT2 N0, M0 lesions (If 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 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 LC-MS/MS, <300 mg/dL and/or free testosterone by
equilibrium dialysis <60 pg/mL.

* 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, DHEA, estrogens, GnRH analogs, antiandrogens,
spironolactone,ketoconazole, rhGH, or megesterol 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

- AST greater than 3x ULN

- 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 CPAP, BiPAP, 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