An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year
Sponsor study identifier
observational
300
1 country
1
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 19, 2008
Actual (reported)June 23, 2008
Actual (reported)June 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Significant difference in FACT-P scores after 12 months between the 2 groups
12 months
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
Patients who have been identified as having a doubling in PSA from nadir of greater than one year
Patients who have been identified as having a doubling in PSA from nadir of less than one year.
Male subjects aged 18 years or older with histologically-confirmed prostate cancer, showing biochemical failure (defined as a rising PSA) following definitive therapy (surgery or radiation) and indicated to receive hormone therapy.
Urology South Shore Research Inc.
Greenfield Park, Quebec, J4V 2H3, Canada
Lorne Aaron, MD
First Submitted
June 19, 2008
First Posted
June 23, 2008
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 17, 2009
Record last verified: 2009-02
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