A Study of Tadalafil After Radical Prostatectomy

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer

• have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))

• develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery

• have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study

• agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study

• does not require the initiation of adjuvant therapy for prostate cancer

Exclusion Criteria:

• history of ED

• have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor

• have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer

• have a history of prostatic surgery or prostatic physical treatments

• have a history of diabetes mellitus

• have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption

• have clinically significant renal insufficiency as determined by the investigator