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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175383
First received: September 11, 2005
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: luteinizing hormone-releasing hormone (LHRH) short acting or long acting
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Short Versus Long Acting LHRH Agonist Preparation Prior to Transperineal Implantation of the Prostate

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA profile, quality of life, sexual function [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175383

Contacts
Contact: Shelley Hordiyuk, BSc., MBA 250-519-5512 SHordiyu@bccancer.bc.ca

Locations
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         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dr. Eric Berthelet, MD The University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175383     History of Changes
Other Study ID Numbers: R03-1213
Study First Received: September 11, 2005
Last Updated: April 9, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Prostate cancer, LHRH, hormone therapy, testosterone level

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014