Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year

February 13, 2009 updated by: Urology South Shore Research Inc.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Recruiting
        • Urology South Shore Research Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorne Aaron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant difference in FACT-P scores after 12 months between the 2 groups
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urology South Shore Research Inc.

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Lorne Aaron, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 23, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8664L00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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