Can Tadalafil (Cialis)® Maintain Erectile Function In Patients Treated With External-Beam Radiotherapy For Prostate Cancer? A Randomized, Double-Blind, Placebo-Controlled Study
It will be a double-blind, placebo-controlled, randomized trial. Patients scheduled for
external-beam radiotherapy for prostate cancer will start using tadalafil 20 mg or placebo
the first day of radiation. The blinded medication (active drug or placebo) has to be taken
once every two days starting the day of the first radiation up to 12 months (52 weeks) after
radiotherapy. The active drug or placebo may be taken at bedtime unrelated to sexual
activity. In case of side effects the dose can be reduced to 10 mg. Erectile function will
be assessed every 3 months up to 6 weeks (week 58) after discontinuation of drug treatment
by using questions 3 and 4 of the International Index of Erectile Function (IIEF).
Responders (maintained erectile function) are defined as having a combined score of >=8 for
the IIEF questions 3 and 4.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
To assess the efficacy, and safety, of 20 mg tadalafil once every 2 days, in comparison with placebo, to maintain erectile function of patients undergoing external-beam radiotherapy for prostate cancer.
Luca Incrocci, MD, PhD
Netherlands: Medical Ethics Review Committee (METC)