Viewing Study NCT00175383



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Last Modification Date: 2024-10-26 @ 9:16 AM
Study NCT ID: NCT00175383
Status: UNKNOWN
Last Update Posted: 2013-04-11
First Post: 2005-09-11

Brief Title: Long Acting LHRH Versus Short Acting LHRH in the Treatment of Prostate Cancer
Sponsor: University of British Columbia
Organization: University of British Columbia

Study Overview

Official Title: A Randomized Trial of Short Versus Long Acting LHRH Agonist Preparation Prior to Transperineal Implantation of the Prostate
Status: UNKNOWN
Status Verified Date: 2013-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Brachytherapy or Transperineal implantation of the prostate TPIP is a recognized form of treatment for localized cancer of the prostate TPIP has been used at the British Columbia Cancer Agency BCCA since 1998 As part of the treatment some patients also require hormone therapy for 6 months This is given as injections of a drug called an LHRH agonist The LHRH agonist is made either as short-acting 1-month or long-acting 3 month injections The LHRH agonist lowers testosterone levels which helps make delivery of TPIP easier and more effective

There are specific guidelines regarding the use of LHRH agonist treatment with brachytherapy however there is no policy whether short-acting or long-acting LHRH agonists should be used

Analysis of results from BC has shown that there seems to be a delay in the time in which testosterone levels return to normal in men who receive the long-acting LHRH agonist compared with the short-acting LHRH agonist however this is not known for sure
Detailed Description: The suppression of testosterone to castrate levels has a definite advantage in terms of prostate volume downsizing disease control and ease of Brachytherapy in this patient population The improved potency preservation rate seen with brachytherapy when compared to other treatments such as radical prostatectomy or external beam may be an important determinant in the patients choice of treatment modality Hence testosterone recovery should be an important endpoint to consider in this patient population since prolongation of testosterone suppression may also delay the return of erectile function

In order to compare the impact of LHRH agonist preparations on the rate of testosterone recovery we propose a randomized clinical trial using one versus three-month Leuprolide preparations in patients otherwise suitable for our Brachytherapy Program

The primary objective of this study is the median time to testosterone recovery in patients receiving 6 X 1-month or 2 X 3-month LHrH preparations and TPIP as radical treatment for limited stage prostate cancer

In this context testosterone recovery is defined as the return to the lower limit of normal for the patients age group as well as return to pre treatment levels

Analysis will mainly focus on time to testosterone recovery as defined by return to the lower limit of normal for the patients age group as well as return to pre treatment levels The lower limits of normal are defined as 58nmolL and 55nmolL for 50 and 50 years old

Changes in PSA level QOL and erectile function will also be recorded

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