S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Follow-up


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Randomized on PCPT Diagnosed with prostate cancer on or before December 31, 2003 DISEASE CHARACTERISTICS: Diagnosed by either study site or central pathology review PATIENT CHARACTERISTICS: See inclusion criteria PRIOR CONCURRENT THERAPY: Not Applicable

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long Term Follow-Up<br>Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT) | Other: Follow-up<br>* No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT<br>* Other names: Observation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to metastases |  | Up to 8 years post registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to secondary therapy after definitive therapy | Definitive therapy is defined as radiotherapy or radical prostatectomy. | Up to 8 years post registration | 
| Time to PSA recurrence after definitive therapy | Definitive therapy is defined as radiotherapy or radical prostatectomy. | Up to 8 years post registration | 
| All cause and prostate cancer-specific mortality | Measured in a time-to-event analysis | Up to 8 years post registration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer