NCT02499497

A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved LY SARM/LY2452473 as a treatment for any disease. In this research study, the investigators are studying a new investigational drug called LY SARM (LY2452473). Concerns about the potential adverse effects of testosterone on the prostate have led to the development of molecules called SARMs (Selective Androgen Receptor Modulators). This investigational drug may improve sexual function, quality of life, muscle and bone mass in men with prostate cancer. This molecule was chosen because there is some evidence that shows it may help to improve sexual function and aid in the improvement of muscle mass while not having any influence on the prostate.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	LY2452473	LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
DRUG	Placebo	The participants will receive pills containing no active drug.

Timeline

• Start date: 2016-02-29
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2015-07-16
• Last updated: 2021-09-28
• Results posted: 2021-09-28

Locations

4 sites across 1 country: United States