Prostate Cancer Clinical Trial
Official title:
Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer
RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as
finasteride, in patients with prostate cancer may help doctors plan better treatment and
follow-up care.
PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer
while undergoing treatment with either finasteride or a placebo on the Prostate Cancer
Prevention Trial (PCPT).
OBJECTIVES:
- 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.
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Observational Model: Cohort, Time Perspective: Prospective
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