GUMDROP : RTOG 0831 A Randomized, Double-blind, 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

Created by Marte, Jenn (NIH/NCI) [E], last modified by Channing Paller on Apr 14, 2012

Description:

This randomized phase III trial is studying tadalafil to see how well it works compared with a placebo in preventing erectile dysfunction in patients with prostate cancer treated with radiation therapy. Eligibility includes patients with clinical stage T1b-T2b disease, lymph nodes less than 1.5 cm, and no bone metastases. The primary outcome measure is spontaneous (off-drug) erectile function (EF) as measured by International Index of Erectile Function (IIEF) at weeks 28-30.

Link:

http://www.clinicaltrials.gov/ct2/show/NCT00931528

Site:

JHMI, RTOG

Principal Investigator:

Song, Deborah Bruner