Prostate CancerNCT00175383
Long Acting LHRH Versus Short Acting LHRH in the Treatment of Prostate Cancer
A study testing luteinizing hormone-releasing hormone (LHRH) short acting or long acting in people with Prostate Cancer, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- luteinizing hormone-releasing hormone (LHRH) short acting or long acting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2004to Feb 2008
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5
About this study
Official title: 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.
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- luteinizing hormone-releasing hormone (LHRH) short acting or long acting
- Keywords
- Prostate cancer, LHRH, hormone therapy, testosterone level
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteinizing hormone-releasing hormone (LHRH) short acting or long actingDrug
See Detailed Description.
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide preparations | Experimental | One versus three-month Leuprolide preparations in patients otherwise suitable for our Brachytherapy Program Receives: Drug: luteinizing hormone-releasing hormone (LHRH) short acting or long acting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Eric Berthelet, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175383
- Sponsor's protocol ID
- R03-1213
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2005
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No