Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 961
- Locations
- 52
- Primary Endpoint
- Time to metastases
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to metastases
Time Frame: Up to 8 years post registration
Secondary Outcomes
- Time to PSA recurrence after definitive therapy(Up to 8 years post registration)
- Time to secondary therapy after definitive therapy(Up to 8 years post registration)
- All cause and prostate cancer-specific mortality(Up to 8 years post registration)