Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
- Conditions
- Prostate Cancer
- Registration Number
- NCT00703768
- Lead Sponsor
- Urology South Shore Research Inc.
- Brief Summary
The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
- 18 years or older
- Received therapy of curative intent (surgery or radiotherapy)
- Have a rising PSA which has doubled from a nadir value.
- Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months
- Written informed consent to participate in the trial.
Exclusion Criteria
- Known hypersensitivity to Zoladex, Casodex, ar any component of these products
- Prior treatment with LHRH agonist or anti-androgens in the past 12 months
- Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Significant difference in FACT-P scores after 12 months between the 2 groups 12 months
- Secondary Outcome Measures
Name Time Method PSA response 12 months To evaluate the ease of use of FACT-P to measure Quality of Life 12 months QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy 12 months
Trial Locations
- Locations (1)
Urology South Shore Research Inc.
🇨🇦Greenfield Park, Quebec, Canada