Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy
A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedAugust 13, 2010
August 1, 2010
5.2 years
September 8, 2005
August 12, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To compare 2 schedules of MeloxicamTM given in the peri-operative period to reduce prostate swelling after permanent seed implantation for prostate cancer
Secondary Outcomes (1)
To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Crook J, Patil N, Wallace K, Borg J, Zhou D, Ma C, Pond G. A phase III randomized trial of the timing of meloxicam with iodine-125 prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):496-501. doi: 10.1016/j.ijrobp.2009.04.078. Epub 2010 Mar 28.
PMID: 20350785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juanita Crook, MD
Princess Margaret Hospital, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 9, 2005
Study Start
February 1, 2004
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 13, 2010
Record last verified: 2010-08