Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?

NCT00215631 | Terminated Phase 3

• 1 other identifier: 2004-165
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Because of the high incidence of post-radiation erectile dysfunction (ED), up to 72% after external-beam radiotherapy, this patient category represents a most difficult therapeutic challenge. Therefore, prevention of ED could be more effective than treatment. Tadalafil, a new phosphodiesterase type 5 inhibitor, has been recently introduced. No studies have investigated the efficacy of tadalafil in preventing ED in patients undergoing radiotherapy for prostate cancer. Efficacy of tadalafil can last up to 36 hours after intake. This will result in a prolonged and continuos enhancement of penile vascular responsiveness. This randomized, double-blind, placebo-controlled study has been designed to evaluate the efficacy of 20-mg of tadalafil administered for 12 months in maintaining erectile function of potent patients undergoing external-beam radiotherapy for prostate cancer.

Conditions

Prostate Cancer; Erectile Dysfunction

Keywords

prostate cancer; radiotherapy; erectile dysfunction; tadalafil

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Erectile function defined as the sum of questions 3 and 4 of the IIEF questionnaire every 3 months till the end of the study (at 3-6-12-24 months).

• Erectile function domain of the IIEF, defined as the sum of questions 1-5, and 15 of the IIEF questionnaire, questions 2 and 3 of the Sexual Encounter Profile (SEP), and responses to the other questions of the IIEF, at 3-6-12-24 months after initiation

Interventions

tadalafil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men, at least 18 years of age, willing to participate in the study and willing to regularly attempt sexual activity.
• Patients with histologically proven prostate cancer.
• Provide signed informed consent.
• Patients with normal erectile function defined as a combined score \>=8 of questions 3 and 4 of the IIEF.
• Agree not to use any other ED treatment during the study.

You may not qualify if:

• Use of any treatment for ED before the start of the study.
• History of pelvic surgery (including radical prostatectomy)
• History of penile implant
• The presence of penile deformity that makes sexual intercourse difficult or impossible.
• Patients with chronic stable angina treated with long-acting nitrates, or patients with chronic stable angina who have required short-acting nitrates in the last 90 days, or angina occurring during sexual intercourse in the last 6 months.
• Patients with unstable angina, history of myocardial infarction or coronary artery bypass graft surgery or percutaneous coronary intervention (eg, angioplasty or stent placement) within 90 days before screening.
• Any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate \>100 bpm) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate \>100 bpm for 30 sec) despite medical or device therapy, or the presence of an automatic internal cardioverter-defibrillator.
• A history of sudden cardiac arrest despite medical or device therapy.
• Any evidence of congestive heart failure or a new, significant conduction defect within 90 days before screening.
• Systolic blood pressure \>170 or \<90 mm Hg or diastolic blood pressure \>100 or \<50 mm Hg, or patients with a history of malignant hypertension.
• History of significant central nervous system injuries (including stroke and spinal cord injury) within the 6 months before screening.
• History of HIV infection.
• Any condition that would interfere with the patient's ability to provide informed consent or comply with study instructions, would place patient at increased risk, or might confound the interpretation of the study results.
• Treatment with cancer chemotherapy.
• History of drug, alcohol, or substance abuse within the 6 months before screening.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC-Daniel den Hoed Cancer

Rotterdam, 3008 AE, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Luca Incrocci, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2005
• Study Completion: November 1, 2005
• Last Updated: September 15, 2015

Record last verified: 2007-04

Locations

NL (1)