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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 (PCPT)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

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 SWOG-S0437
NCT00288106, S0437

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.

Entry 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

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Not specified

Expected Enrollment

2397

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ian Thompson, MD, Protocol chair
Ph: 210-567-5643
Email: thompsoni@uthscsa.edu
Scott Lippman, MD, FACP, Protocol co-chair
Ph: 713-745-3658
E. David Crawford, MD, Protocol co-chair
Ph: 303-315-5936
Email: david.crawford@uchsc.edu

Related Information

PDQ® clinical trial SWOG-9217

Registry Information

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

Trial Start Date		2005-09-01

Trial Completion Date		2009-05-01

Registered in ClinicalTrials.gov		NCT00288106

Date Submitted to PDQ		2005-12-12

Information Last Verified		2009-04-16

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.