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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00703768

Enrollment

300

Registered

2008-06-23

Start date

2006-06-30

Completion date

2010-07-31

Last updated

2009-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Quality of Life, Androgen Deprivation Therapy, Goserelin

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Contacts

Primary ContactLorne Aaron

ussr@bellnet.ca450-671-2945

Backup ContactCarol Paris