Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Urology South Shore Research Inc..
Recruitment status was Recruiting
Information provided by:
Urology South Shore Research Inc.
First received: June 19, 2008
Last updated: February 13, 2009
Last verified: February 2009
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||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
Primary Outcome Measures:
- Significant difference in FACT-P scores after 12 months between the 2 groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PSA response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To evaluate the ease of use of FACT-P to measure Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00703768
|Urology South Shore Research Inc.
|Greenfield Park, Quebec, Canada, J4V 2H3 |
|Contact: Lorne Aaron, MD 450-671-2945 firstname.lastname@example.org |
|Contact: Carol Paris 450-671-2945 email@example.com |
|Principal Investigator: Lorne Aaron, MD |
Urology South Shore Research Inc.
||Lorne Aaron, MD
No publications provided
||Dr. Lorne Aaron, Urology South Shore Research Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 19, 2008
||February 13, 2009
||Canada: Health Canada
Keywords provided by Urology South Shore Research Inc.:
Quality of Life
Androgen Deprivation Therapy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs