Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215631
Status:
TERMINATED
Last Update Posted:
2015-09-15
First Post:
2005-09-18
Brief Title:
Can Tadalafil Maintain Erectile Function In Patients Treated With Radiotherapy For Prostate Cancer
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None