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

Primary Purpose

Prostate Cancer, Erectile Dysfunction

Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
tadalafil
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer, radiotherapy, erectile dysfunction, tadalafil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • Erasmus MC-Daniel den Hoed Cancer

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 18, 2005
Last Updated
September 14, 2015
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00215631
Brief Title
Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer?
Official Title
Can Tadalafil (Cialis)® Maintain Erectile Function In Patients Treated With External-beam Radiotherapy For Prostate Cancer? A Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Erasmus Medical Center

4. Oversight

5. Study Description

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.
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 radiation. The blinded medication (active drug or placebo) has to be taken once every two days starting the day of the first radiation up to 12 months (52 weeks) after radiotherapy. The active drug or placebo may be taken at bedtime unrelated to sexual activity. In case of side effects the dose can be reduced to 10 mg. Erectile function will be assessed every 3 months up to 6 weeks (week 58) after discontinuation of drug treatment by using questions 3 and 4 of the International Index of Erectile Function (IIEF). Responders (maintained erectile function) are defined as having a combined score of >=8 for the IIEF questions 3 and 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Erectile Dysfunction
Keywords
prostate cancer, radiotherapy, erectile dysfunction, tadalafil

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tadalafil
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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).
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Incrocci, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC-Daniel den Hoed Cancer
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands

12. IPD Sharing Statement

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

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