A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

• Status: Completed
• Trial end date: 2020-10-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Institute of Nursing Research (NINR)
• Treatments: Androgens

Criteria

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