A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Protocol # :
Prostate Cancer
Disease Sites
Principal Investigator
Bhasin, Shalender

Trial Description

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

Eligibility Requirements

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

- 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

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