Status:
UNKNOWN
PR.7 Companion Trial: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition
Lead Sponsor:
Ontario Cancer Research Network
Conditions:
Prostate Cancer
Eligibility:
All Genders
Brief Summary
The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of os...
Detailed Description
Primary Objectives: 1. To compare CAS and IAS with respect to bone mineral density (BMD): We will determine whether the bone loss associated with long term CAS can be reduced by IAS by evaluation of:...
Eligibility Criteria
Inclusion
- Histologically confirmed PCa
- Completed radiotherapy to the prostatic area more than 12 months prior to randomization
- Rising PSA level (serum PSA \> 3 ng/ml (3 μg/L)) and higher than the lowest level recorded previously since the end of radiotherapy (i.e. higher than the post-radiotherapy nadir)
- No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
- No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization.
Exclusion
- Severe osteoporosis
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
End Date :
April 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00228124
Start Date
April 1 2004
End Date
April 1 2008
Last Update
January 26 2006
Active Locations (1)
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1
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5