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

NCT00175383 | Unknown Phase 3

• 1 other identifier: R03-1213
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer, LHRH, hormone therapy, testosterone level

Outcome Measures

Primary Outcomes (2)

• 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.

  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 Outcomes (1)

• PSA profile, quality of life, sexual function

Study Arms (1)

Leuprolide preparations

EXPERIMENTAL

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

Interventions

luteinizing hormone-releasing hormone (LHRH) short acting or long acting DRUG

See Detailed Description.

Leuprolide preparations

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• PSA \> 10 but \< 15 and Gleason score \< 7, OR
• PSA \< 10 and Gleason score = 7 OR
• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Dr. Eric Berthelet, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Hordiyuk, BSc., MBA

CONTACT

250-519-5512; SHordiyu@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

CA (1)