Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

Phase 3 Completed 242 enrolled Radiation Therapy Oncology Group NRG Oncology · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupTriple-blindSupportive care

Summary

RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction. PURPOSE: 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.

Timeline

Start: 2009-11
Primary completion: 2012-12
Completion: 2014-11

Outcome

Missed primary endpoint

paper Among men undergoing radiotherapy for prostate cancer, daily use of tadalafil compared with placebo did not result in improved erectile function. PMID 24691606 ↗

Publications

Pisansky TM, Pugh SL, Greenberg RE, Pervez N, Reed DR, Rosenthal SA, Mowat RB, Raben A, Buyyounouski MK, Kachnic LA, Bruner DW. Tadalafil for prevention of erectile dysfunction after radiotherapy for prostate cancer: the Radiation Therapy Oncology Group [0831] randomized clinical trial. JAMA. 2014 Apr 2;311(13):1300-7. doi: 10.1001/jama.2014.2626.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	5 mg	Oral