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

This study is currently recruiting participants.

Verified by Urology South Shore Research Inc., February 2009

First Received: June 19, 2008 Last Updated: February 13, 2009 History of Changes

Sponsors and Collaborators:	Urology South Shore Research Inc. AstraZeneca
Information provided by:	Urology South Shore Research Inc.
ClinicalTrials.gov Identifier:	NCT00703768

Purpose

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.

Condition
Prostate Cancer

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	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

Further study details as provided by Urology South Shore Research Inc.:

Primary Outcome Measures:

Significant difference in FACT-P scores after 12 months between the 2 groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	June 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703768

Contacts

Contact: Lorne Aaron	450-671-2945	ussr@bellnet.ca
Contact: Carol Paris	450-671-2945	ussr@bellnet.ca

Locations

Canada, Quebec
Urology South Shore Research Inc.	Recruiting
Greenfield Park, Quebec, Canada, J4V 2H3
Contact: Lorne Aaron, MD 450-671-2945 ussr@bellnet.ca
Contact: Carol Paris 450-671-2945 ussr@bellnet.ca
Principal Investigator: Lorne Aaron, MD

Sponsors and Collaborators

Urology South Shore Research Inc.

AstraZeneca

Investigators

Principal Investigator:

Lorne Aaron, MD

Unaffiliated

More Information

No publications provided

Responsible Party:	Urology South Shore Research Inc. ( Dr. Lorne Aaron )
Study ID Numbers:	D8664L00006
Study First Received:	June 19, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00703768 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Urology South Shore Research Inc.:

Quality of Life
Androgen Deprivation Therapy
Goserelin

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Quality of Life

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on May 07, 2009