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Long-Term Follow-Up Study of Patients Who Were Diagnosed With Prostate Cancer While Undergoing Treatment on a Prostate Cancer Prevention Trial

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Natural history/Epidemiology Completed 55 and over at time of enrollment to SWOG-9217 NCI, Other CDR0000466341
SWOG-S0437, NCT00288106

Trial Description

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).

Further Study Information

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: Approximately 2,397 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosed with prostate cancer on or before December 31, 2003

Previously randomized in the Prostate Cancer Prevention Trial SWOG-9217 to receive either finasteride or a placebo

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

Ian Murchie Thompson

Study Chair

Scott Michael Lippman

E. David Crawford

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00288106
Information obtained from ClinicalTrials.gov on January 20, 2010

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.