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

NCT ID: NCT00703768

Last Updated: 2009-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients who have been identified as having a doubling in PSA from nadir of greater than one year

No interventions assigned to this group

B

Patients who have been identified as having a doubling in PSA from nadir of less than one year.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Urology South Shore Research Inc.

OTHER

Sponsor Role lead

Responsible Party

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Urology South Shore Research Inc.

Principal Investigators

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Lorne Aaron, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Urology South Shore Research Inc.

Greenfield Park, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lorne Aaron

Role: CONTACT

450-671-2945

Carol Paris

Role: CONTACT

450-671-2945

Facility Contacts

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Lorne Aaron, MD

Role: primary

450-671-2945

Carol Paris

Role: backup

450-671-2945

Other Identifiers

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D8664L00006

Identifier Type: -

Identifier Source: org_study_id

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