RTOG 0831: Prostate Cancer
RTOG 0831: A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED PHASE III TRIAL TO EVALUATE THE EFFECTIVENESS OF A PHOSPHODIESTERASE 5 INHIBITOR, TADALAFIL, IN PREVENTION OF ERECTILE DYSFUNCTION IN PATIENTS TREATED WITH RADIOTHERAPY FOR PROSTATE CANCER (PREVENTION OF ERECTILE DYSFUNCTION STUDY [PEDS])
Approval Date: 12/31/1969
Principal Investigator: Howard Korman, M.D.
You are being asked to take part in this study because you have prostate cancer and as part of your treatment, you are receiving radiation therapy.
The purpose of this study is to compare the effects, both good and bad, of a drug, tadalafil, with a placebo (an inactive drug). Tadalafil is given as a treatment for erectile dysfunction (inability to maintain an erection long enough to engage in sexual intercourse). This study is being done to find out if tadalafil prevents erectile dysfunction in men with prostate cancer who are undergoing radiation therapy (that is, if the drug helps the participants taking it to maintain an erection following sexual stimulation). In this study, you will get tadalafil or placebo. You will not get both.
- Age 18 years or older
- No previous penile implant
- No prior surgery to remove both testicles
- No previous surgery, cryosurgery, high intensity focused ultrasound, radionuclide implant, or chemotherapy for prostate cancer
Status of Clinical Trial:
open and not enrolling