Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Interventions
OTHERFollow-up
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
55 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to metastases | Up to 8 years post registration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to secondary therapy after definitive therapy | Up to 8 years post registration | Definitive therapy is defined as radiotherapy or radical prostatectomy. |
| Time to PSA recurrence after definitive therapy | Up to 8 years post registration | Definitive therapy is defined as radiotherapy or radical prostatectomy. |
| All cause and prostate cancer-specific mortality | Up to 8 years post registration | Measured in a time-to-event analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Predictive value of prognostic biomarkers | Up to 8 years post registration | To enhance the follow-up for the evaluation of the prognostic biomarkers, which are measured outside the scope of this protocol, on the risk of metastatic disease. |
Countries
United States
Outcome results
None listed