A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
The SARM Prostate Cancer Study is a Phase II research study in which eligible men are invited to participate in a sixteen week study to evaluate the effects of an oral study drug called LY SARM on sexual function, Health Related Quality of Life, muscle mass, and muscle strength. This research is being done to study an investigational drug called LY SARM (LY2452473). The use of LY SARM in this research study is investigational. The word “investigational” means that LY SARM is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of LY SARM in this study. Concerns about the potential adverse effects of testosterone on the prostate have led to the development of molecules called SARMs (Selective Androgen Receptor Modulators). Androgens are a group of hormones that play a role in male traits and reproductive activity. 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. The LY SARM molecule acts in a similar way that testosterone does to cause its effects on the muscle, bone and sexual function. However, because of the differences in the structure of this SARM molecule from that of testosterone, it differs from testosterone in some of its properties. Most importantly, unlike testosterone, LY SARM does not stimulate prostate growth; in fact, LY SARM may block testosterone’s effects on the prostate. LY SARM improves sexual function and muscle mass but is associated with a decrease in the size of the prostate, unlike testosterone which improves sexual function and muscle mass but stimulates the growth of the prostate. Hence; LY SARM is being studied as a treatment for large prostates and prostate cancer.
Men with prostate cancer and who have undergone radical prostatectomy may join.This research is being done to learn more about whether LY SARM is beneficial and safe in improving sexual function, health related quality of life, muscle mass and muscle strength in men age 19 and older who have undergone prostate removal for prostate cancer and are considered cured.
If you decide to participate in the study and qualify on screening, you will be randomized into 1 of 3 groups. Randomization means that you are put into a group by chance, like drawing numbers from a hat. Neither you nor the research doctor will choose what group you will be in. You will have a 1 in 3 chance of being placed in any of the following groups: • The placebo (pills with no medicine) group; • The smaller dose of study drug group; or • The larger dose of the study drug group. You will be given a study drug and it will contain either a larger dose of LY SARM, a smaller dose of LY SARM, or a placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. If you take part in this research study you will be given a drug diary. You will be asked to document information in the drug diary about the study drug regimen you are being asked to take.
03/05/2019 05:03 AM