Status:
TERMINATED
Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?
Lead Sponsor:
Erasmus Medical Center
Conditions:
Prostate Cancer
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
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. Therefor...
Detailed Description
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 radi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00215631
Start Date
October 1 2005
End Date
November 1 2005
Last Update
September 15 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasmus MC-Daniel den Hoed Cancer
Rotterdam, Netherlands, 3008 AE