Tadalafil May Be Helpful for Erectile Dysfunction in Men With Prostatic Carcinoma

Laurie Barclay, MD

October 05, 2006

October 5, 2006 -- Treatment with tadalafil in men with erectile dysfunction after radiotherapy for prostatic carcinoma was effective and well tolerated, according to the results of a study reported in the October issue of the International Journal of Radiation Oncology, Biology and Physics.

"Erectile dysfunction after three-dimensional conformal external-beam radiotherapy (3DCRT) for prostatic carcinoma is reported in as many as 64% of those patients," write Luca Incrocci, MD, PhD, from the Erasmus MC-Daniel den Hoed Cancer Center in Rotterdam, the Netherlands, and colleagues. "The purpose of this study was to determine the efficacy of the oral drug tadalafil (Cialis) in patients with erectile dysfunction after radiotherapy for prostatic carcinoma."

Of 358 patients contacted by mail who completed 3DCRT at least 12 months before the study, 60 patients were enrolled in a double-blind, placebo-controlled, cross-over study lasting 12 weeks. Patients received 20 mg of tadalafil or placebo for 6 weeks, taken on demand at their discretion (at least once a week and no more than once daily), with no restrictions regarding the consumption of alcohol or food. At 6 weeks, patients crossed over to the other treatment. Outcome measures included responses on the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF) questionnaires, as well as adverse effects.

Mean age at study enrollment was 69 years; all patients completed the study. With tadalafil, but not with placebo, there was a significant increase in mean scores from baseline for almost all questions of the IIEF questionnaire. Improvement of erectile function was reported with tadalafil by 67% of the patients compared with 20% of those receiving placebo. Successful intercourse was reported by 48% of those in the tadalafil group vs 9% of those in the placebo group ( P < .0001). Adverse effects were mild or moderate.

Study limitations include lack of data with the 10-mg dose and the absence of data on erectile function before radiotherapy.

"Tadalafil is an effective treatment for erectile dysfunction after 3DCRT for prostatic carcinoma with successful intercourse reported in almost 50% of the patients, and it is well tolerated," the authors write. "Because of the simplicity of delivery, its efficacy, and tolerability, tadalafil is a good treatment option for patients with ED after radiotherapy for [prostatic carcinoma], who are not using nitrates."

Lilly Icos provided drugs and placebo and an unrestricted grant to cover patients' visits and administration costs.

Int J Radiat Oncol Biol Phys. 2006;66:439-444.

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