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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703768
First Posted: June 23, 2008
Last Update Posted: February 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
Urology South Shore Research Inc.
June 19, 2008
June 23, 2008
February 17, 2009
June 2006
June 2010   (Final data collection date for primary outcome measure)
Significant difference in FACT-P scores after 12 months between the 2 groups [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00703768 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
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
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Prostate Cancer
Not Provided
  • A
    Patients who have been identified as having a doubling in PSA from nadir of greater than one year
  • B
    Patients who have been identified as having a doubling in PSA from nadir of less than one year.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
July 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00703768
D8664L00006
No
Not Provided
Not Provided
Dr. Lorne Aaron, Urology South Shore Research Inc.
Urology South Shore Research Inc.
AstraZeneca
Principal Investigator: Lorne Aaron, MD
Urology South Shore Research Inc.
February 2009