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Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer

55 Years
Not Enrolling
Prostate Cancer

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Trial Information

Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer


- Compare the time to metastases in patients who were diagnosed with high grade or low
grade prostate cancer on or before December 31, 2003 and were treated with finasteride
or placebo while enrolled on the Prostate Cancer Prevention Trial (SWOG-9217).

- Compare the difference in time to secondary therapy after definitive therapy with
radiotherapy or radical prostatectomy in these patients.

- Compare the difference in time to prostate-specific antigen recurrence after definitive
therapy with radiotherapy or radical prostatectomy in these patients.

- Compare the difference in all-cause and prostate cancer mortality in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to survival status
(alive vs deceased).

Patients provide information about their general health, prostate cancer treatment history,
prostate cancer status (i.e., disease progression and metastases data), and
prostate-specific antigen (PSA) test results at baseline and then every 6 months for up to 8
years. Next of kin of deceased patients are asked to release the patients' medical records
in order to obtain information about the patients' prostate cancer treatment history,
prostate cancer progression and metastases, PSA test results, and cause of death.

PROJECTED ACCRUAL: A minimum of 75% of the 2,401 patients (n=1800) diagnosed with prostate
cancer on PCPT are needed to have minimal power to evaluate the objectives.

Inclusion Criteria


- Randomized on PCPT

- Diagnosed with prostate cancer on or before December 31, 2003


- Diagnosed by either study site or central pathology review


- See inclusion criteria


- Not Applicable

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to metastases

Outcome Time Frame:

Up to 8 years post registration

Safety Issue:


Principal Investigator

Ian M. Thompson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio


United States: Federal Government

Study ID:




Start Date:

September 2005

Completion Date:

May 2009

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



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