A Study to Assess the Efficacy of Tadalafil to Treat Erectile Dysfunction After Radiotherapy of Prostate Cancer

NCT00122499 | Completed Phase 3

• 1 other identifier: 232.476/2003/180
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed to evaluate the efficacy and safety of a 20-mg dose of tadalafil administered "on demand" to patients with erectile dysfunction (ED) after external-beam radiotherapy (EBRT) of prostate cancer.

Conditions

Prostate Cancer; Erectile Dysfunction

Keywords

Prostate cancer; Radiotherapy; Erectile dysfunction; Tadalafil

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of 20 mg tadalafil, in comparison with placebo, in men with ED after 3-D conformal radiotherapy (3DCRT) of prostate cancer

Secondary Outcomes (2)

• Responses to the Global Assessment Questions (GAQ), and the other items of the Sexual Encounter Profile (SEP) and International Index of Erectile Function (IIEF)

• To assess the side effects of 20 mg tadalafil in men with ED after 3DCRT

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:

• Heterosexual men, at least 18 years of age at Visit 1 and willing to participate in the study. If a qualifying participant has more than one female sexual partner during the study, the participant will not be excluded from the trial. However, the participant will be required to respond to the questionnaires based on the participant's sexual interactions with only one of these partners.
• Patients with histologically proven prostate cancer.
• Provide signed informed consent.
• Developed ED (defined as a consistent change in the quality of erection that adversely affects the patient's satisfaction with sexual intercourse) subsequent to EBRT for prostate cancer.
• Patients willing to make on average 1 sexual intercourse attempt every week during the study (including the 4-week run-in period without medication).
• Agree not to use any other ED treatment for at least 4 weeks before receiving the initial dose of study drug (ie, during the run-in period and during the treatment phase of the study).
• Have been treated by EBRT at least 12 months before screening and were documented to be potent before undergoing EBRT.

You may not qualify if:

• Patients will not be randomized if they did not make at least 1 sexual intercourse attempt during the run-in period. Also patients who are unable to appropriately complete the questionnaires will not be randomized.
• ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease (eg, hypopituitarism, hypothyroidism, or hypogonadism).
• History of pelvic surgery (including radical prostatectomy)
• Treatment with cancer chemotherapy or anti-androgens.
• Have a raising prostate specific antigen level or metastases at Visit 1.
• History of penile implant.
• The presence of clinically significant penile deformity in the opinion of the investigator.
• Evidence of clinically significant renal insufficiency within the last 6 months before Visit 1.
• Active symptomatic hepatobiliary disease, including patients with evidence of jaundice at Visit 1.
• 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 having met the criteria for unstable angina (Braunwald, 1989) within 6 months before Visit 1, history of myocardial infarction or coronary artery bypass graft surgery within 90 days before Visit 1, or percutaneous coronary intervention (eg, angioplasty or stent placement) within 90 days before Visit 1.
• 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 class 2 or above within 6 months before Visit 1 (Criteria Committee, New York Heart Association, Inc., 1964).
• A new, significant conduction defect within 90 days before Visit 1.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

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, M.D., Ph.D.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: February 1, 2003
• Study Completion: February 1, 2005
• Last Updated: July 27, 2005

Record last verified: 2005-07

Locations

NL (1)