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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Urology South Shore Research Inc..
Recruitment status was:  Recruiting
Information provided by:
Urology South Shore Research Inc. Identifier:
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.

Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Urology South Shore Research Inc.:

Primary Outcome Measures:
  • Significant difference in FACT-P scores after 12 months between the 2 groups [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • PSA response [ Time Frame: 12 months ]
  • To evaluate the ease of use of FACT-P to measure Quality of Life [ Time Frame: 12 months ]
  • QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy [ Time Frame: 12 months ]

Estimated Enrollment: 300
Study Start Date: June 2006
Estimated Study Completion Date: July 2010
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   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00703768

Contact: Lorne Aaron 450-671-2945
Contact: Carol Paris 450-671-2945

Canada, Quebec
Urology South Shore Research Inc. Recruiting
Greenfield Park, Quebec, Canada, J4V 2H3
Contact: Lorne Aaron, MD    450-671-2945   
Contact: Carol Paris    450-671-2945   
Principal Investigator: Lorne Aaron, MD         
Sponsors and Collaborators
Urology South Shore Research Inc.
Principal Investigator: Lorne Aaron, MD
  More Information

Responsible Party: Dr. Lorne Aaron, Urology South Shore Research Inc. Identifier: NCT00703768     History of Changes
Other Study ID Numbers: D8664L00006
Study First Received: June 19, 2008
Last Updated: February 13, 2009

Keywords provided by Urology South Shore Research Inc.:
Quality of Life
Androgen Deprivation Therapy

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 22, 2017