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A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Not Enrolling

Trial ID:NCT02499497

View complete trial on ClinicalTrials.gov

Protocol #:15-120

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer

Phase:II

Principal Investigator:Bhasin, Shalender

Site Research Nurse(s):Schram, Haley, J.

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 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

Protocol #: 15-120

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)