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

Urology South Shore Research Inc.

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00703768

D8664L00006

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

300 participants in 2 patient groups

A

Description:

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

B

Description:

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