S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
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|ClinicalTrials.gov Identifier: NCT00288106|
Recruitment Status : Terminated (Poor accrual resulted in lack of feasibility to evaluate endpoints.)
First Posted : February 7, 2006
Last Update Posted : September 30, 2015
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).
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: Follow-up|
- 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 Type :||Observational|
|Actual Enrollment :||961 participants|
|Official Title:||Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Long Term Follow-Up
Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Other Name: Observation
- Time to metastases [ Time Frame: Up to 8 years post registration ]
- Time to secondary therapy after definitive therapy [ Time Frame: Up to 8 years post registration ]Definitive therapy is defined as radiotherapy or radical prostatectomy.
- Time to PSA recurrence after definitive therapy [ Time Frame: Up to 8 years post registration ]Definitive therapy is defined as radiotherapy or radical prostatectomy.
- All cause and prostate cancer-specific mortality [ Time Frame: Up to 8 years post registration ]Measured in a time-to-event analysis
- Predictive value of prognostic biomarkers [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288106
|Study Chair:||Ian M. Thompson, MD||The University of Texas Health Science Center at San Antonio|
|Study Chair:||Scott M. Lippman, MD, FACP||M.D. Anderson Cancer Center|
|Study Chair:||E. David Crawford, MD||University of Colorado, Denver|