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
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Urology South Shore Research Inc.
ClinicalTrials.gov Identifier:
NCT00703768
First received: June 19, 2008
Last updated: February 13, 2009
Last verified: February 2009

June 19, 2008
February 13, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00703768 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
 
Recruiting
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.
Female
18 Years and older
No
Contact: Lorne Aaron 450-671-2945 ussr@bellnet.ca
Contact: Carol Paris 450-671-2945 ussr@bellnet.ca
Canada
 
NCT00703768
D8664L00006
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP