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S0437 Long-Term Follow-Up Study of Patients Who Were Diagnosed With Prostate Cancer While Undergoing Treatment on a Prostate Cancer Prevention Trial
This study has been completed.

First Received on February 6, 2006.   Last Updated on July 21, 2011   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00288106
  Purpose

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 Intervention
Prostate Cancer
 Other: clinical observation
Procedure: quality-of-life assessment

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Estimated Enrollment: 2397
Study Start Date: September 2005
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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: Approximately 2,397 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288106

  Show 52 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Ian M. Thompson, MD University of Texas
Study Chair: Scott M. Lippman, MD, FACP M.D. Anderson Cancer Center
Study Chair: E. David Crawford, MD University of Colorado, Denver
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Laurence H. Baker, D.O., Chairman, SWOG
ClinicalTrials.gov Identifier: NCT00288106     History of Changes
Other Study ID Numbers: CDR0000466341, U10CA012027, S0437
Study First Received: February 6, 2006
Last Updated: July 21, 2011
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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