Recruiting

Androgen Deprivation Therapy

Sponsor:

Urology South Shore Research Inc.

Code:

NCT00703768

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT00703768

Start date

Jun, 2006

Status verified date

Feb, 2009

Completion date

Jul, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lorne Aaron

450-671-2945ussr@bellnet.ca

Carol Paris

450-671-2945ussr@bellnet.ca

Locations

Urology South Shore Research Inc.

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H3

Contacts

Lorne Aaron, MD

450-671-2945ussr@bellnet.ca

Carol Paris

450-671-2945ussr@bellnet.ca

Principal Investigator:

Lorne Aaron, MD

More Information

Sponsor

Urology South Shore Research Inc.

Last update posted

Feb 17, 2009

Last verified

Feb, 2009

Keywords

  • Quality of Life
  • Androgen Deprivation Therapy
  • Goserelin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Urology South Shore Research Inc. on 2009-02-17.