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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Lorne Aaron, MD

Investigator Role:

Principal Investigator

Authority:

Canada: Health Canada

Study ID:

D8664L00006

NCT ID:

NCT00703768

Start Date:

June 2006

Completion Date:

July 2010

Related Keywords:

  • Prostate Cancer
  • Quality of Life
  • Androgen Deprivation Therapy
  • Goserelin
  • Prostatic Neoplasms

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