A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: LY2452473; Placebo
Intervention description: LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.; The participants will receive pills containing no active drug.
Intervention MeSH terms: Androgens
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 114.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Prostate Cancer

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
    

Eligibility 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