This randomized phase II trial studies the side effects of selective androgen receptor modulator LY2452473 (LY2452473) and how well it works in improving symptom management in patients who have undergone surgery for prostate cancer and have had undetectable prostate-specific antigen (PSA) for 2 or more years after surgery. Reducing the hormone androgen is a way to treat prostate cancer. However, this may cause side effects such as difficulty with sexual function, muscles, and bones, and fatigue. LY2452473 may help reduce the symptoms of androgen deficiency in men with prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02499497.
PRIMARY OBJECTIVES:
I. To compare 0, 1, 5 or 15 mg of selective androgen receptor modulator LY2452473 (LY SARM) in men, who have undergone radical prostatectomy for organ-localized prostate cancer, have symptomatic androgen deficiency and very low risk of disease recurrence, with regard to sexual function (sexual activity score, sexual desire, erectile function, distress and sexual life quality).
SECONDARY OBJECTIVES:
I. To compare the effects of 0, 1, 5 or 15 mg of selective androgen receptor modulator (SARM) on fatigue, well-being and affectivity balance, and disease-specific quality of life.
II. To determine whether SARM administration improves muscle mass and strength, and self-reported and performance-based measures of physical function, and aerobic capacity (maximum volume of oxygen [VO2max], volume of oxygen [VO2] peak, and lactate threshold) more than placebo.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I (PLACEBO): Patients receive placebo orally (PO) once daily (QD) for 12 weeks in the absence of disease progression or unacceptable toxicity.
ARM II (1 MG LY2452473): Patients receive lower dose LY2452473 PO QD for 12 weeks in the absence of disease progression or unacceptable toxicity.
ARM III (5 MG LY2452473): Patients receive higher dose LY2452473 PO QD for 12 weeks in the absence of disease progression or unacceptable toxicity.
ARM IV (15 MG LY2452473): Patients receive highest dose LY2452473 PO QD for 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorShalender Bhasin
