Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause urinary problems ranging from difficulty voiding to urinary retention. The purpose of this study is to investigate whether Mobicox started one week before brachytherapy and then continued afterwards is more effective in reducing the risk of needing a catheter than Mobicox given only afterwards...
Date First Received: September 8, 2005
Last Updated: December 23, 2005
Verified by: University Health Network, Toronto, September 2005
Clinical Trial Phase: Phase 3 | Start Date: February 2004
Overall Status: Recruiting
Estimated Enrollment: 100
Brief Summary
Official Title: “A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial”
Condition Keyword(s):
Intervention(s):
Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause urinary problems ranging from difficulty voiding to urinary retention. The purpose of this study is to investigate whether Mobicox started one week before brachytherapy and then continued afterwards is more effective in reducing the risk of needing a catheter than Mobicox given only afterwards.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
Intervention(s) in this Clinical Trial
- Drug: Meloxicam
Outcome Measures for this Clinical Trial
Primary Measures
- To compare 2 schedules of MeloxicamTM given in the peri-operative period to reduce prostate swelling after permanent seed implantation for prostate cancer
Secondary Measures
- To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Eligible to receive prostate brachytherapy as per the Ontario Provincial Guidelines will be eligible for this study (i.e. prostate specific antigen [PSA] < 10, Gleason score <7, Stage <= T2a)
Exclusion Criteria:
- Patients already taking anti-inflammatory drugs
- Patients with allergic-type reactions, including asthma and urticaria, to aspirin or nonsteroidal anti-inflammatory agents (see product information)
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Health Network, Toronto
Overall Clinical Trial Officials and Contacts
Juanita Crook, MD Principal Investigator Princess Margaret Hospital, Canada
Overall Contact: Juanita Crook, MD 416-946-2919 juanita.crook@rmp.uhn.on.ca
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152919
Study ID Number: UHN REB 03-0840-C
ClinicalTrials.gov Identifier: NCT00152919
Health Authority: Canada: Ethics Review Committee
Clinical Trials Authorship and Review
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