Long Acting LHRH Versus Short Acting LHRH in the Treatment of Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00175383|
Recruitment Status : Unknown
Verified April 2013 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : September 15, 2005
Last Update Posted : April 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: luteinizing hormone-releasing hormone (LHRH) short acting or long acting||Phase 3|
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 patient's 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 patient's 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 patient's age group as well as return to pre treatment levels. The lower limits of normal are defined as 5.8nmol/L and 5.5nmol/L for < 50 and > 50 years old
Changes in PSA level, QOL and erectile function will also be recorded
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Short Versus Long Acting LHRH Agonist Preparation Prior to Transperineal Implantation of the Prostate|
|Study Start Date :||June 2004|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Leuprolide preparations
One versus three-month Leuprolide preparations in patients otherwise suitable for our Brachytherapy Program
Drug: luteinizing hormone-releasing hormone (LHRH) short acting or long acting
See Detailed Description.
- 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. [ Time Frame: 6 months ]
- In this context, testosterone recovery is defined as the return to the lower limit of normal for the patient's age group as well as return to pre treatment levels.
- PSA profile, quality of life, sexual function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175383
|Contact: Shelley Hordiyuk, BSc., MBA||250-519-5512||SHordiyu@bccancer.bc.ca|
|Canada, British Columbia|
|BC Cancer Agency - Vancouver Island Centre||Recruiting|
|Victoria, British Columbia, Canada, V8R 6V5|
|Contact: Shelley Hordiyuk, BSc., MBA 250-519-5512|
|Principal Investigator: Howard Pai|
|Principal Investigator:||Dr. Eric Berthelet, MD||The University of British Columbia|