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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00703768
• Other study ID #: D8664L00006
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2008
• Last updated: February 13, 2009
• Start date: June 2006
• Est. completion date: July 2010

Study information

• Verified date: February 2009
• Source: Urology South Shore Research Inc.
• Contact: Lorne Aaron
• Phone: 450-671-2945
• Email: ussr[@]bellnet.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
Canada	Urology South Shore Research Inc.	Greenfield Park	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Urology South Shore Research Inc.	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant difference in FACT-P scores after 12 months between the 2 groups		12 months	No
Secondary	PSA response		12 months	No
Secondary	To evaluate the ease of use of FACT-P to measure Quality of Life		12 months	No
Secondary	QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy		12 months	No