Clinical Trial: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer

Brief 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 Summary:

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.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Harbor-UCLA 7-day Sexual Function Questionnaire [ Time Frame: 6 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • disease-specific quality of life questionnaire [ Time Frame: 6 Months ]
    HRQOL
  • Fatigue The Functional Assessment of Chronic Illness Therapy (FACIT -1) Fatigue Scale [ Time Frame: 6 Months ]
  • Lean body mass using DXA [ Time Frame: 6 months ]
  • Number of participants with Adverse Events [ Time Frame: 6 months ]
  • muscle strength [ Time Frame: 6 months ]
    The one-repetition maximum (1RM) test
  • Continuous Scale Physical Functional Performance 10 [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: July 6, 2015
Date Started: July 2015
Date Completion: November 2022
Last Updated: March 21, 2017
Last Verified: January 2017