Long Acting LHRH Versus Short Acting LHRH in the Treatment of Prostate Cancer

April 9, 2013 updated by: University of British Columbia

A Randomized Trial of Short Versus Long Acting LHRH Agonist Preparation Prior to Transperineal Implantation of the Prostate

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • Recruiting
        • BC Cancer Agency - Vancouver Island Centre
        • Contact:
          • Shelley Hordiyuk, BSc., MBA
          • Phone Number: 250-519-5512
        • Principal Investigator:
          • Howard Pai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

All patients who elect to undergo brachytherapy for the treatment of adenocarcinoma of the prostate and who are otherwise recommended treatment with LHRH agonist. All patients must have a confirmed histological diagnosis of adenocarcinoma of the prostate and elect to be treated with transperineal implantation of the prostate.

Eligible patients will have confirmed clinical stage T1 or T2 (UICC 1997 staging system) with

  1. PSA > 10 but < 15 and Gleason score < 7, OR
  2. PSA < 10 and Gleason score = 7 OR
  3. Prostate volume > 50cc as measured on trans rectal ultrasound

While criteria 1 and 2 are mutually exclusive, criteria 3 can be present alone or in combination with criteria 1 OR 2.

Otherwise patients should be able to give informed consent and have a life expectancy. 2 years.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure
PSA profile, quality of life, sexual function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Dr. Eric Berthelet, MD, The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R03-1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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