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S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

This study has been terminated.
(Poor accrual resulted in lack of feasibility to evaluate endpoints.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00288106
First received: February 6, 2006
Last updated: September 28, 2015
Last verified: September 2015
History of Changes
  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: Follow-up

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Time to metastases [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to secondary therapy after definitive therapy [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    Definitive therapy is defined as radiotherapy or radical prostatectomy.

  • Time to PSA recurrence after definitive therapy [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    Definitive therapy is defined as radiotherapy or radical prostatectomy.

  • All cause and prostate cancer-specific mortality [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    Measured in a time-to-event analysis


Other Outcome Measures:
  • Predictive value of prognostic biomarkers [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    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.
Enrollment: 961
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Long Term Follow-Up
Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)
 Other: Follow-up
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Other Name: Observation

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.

  Eligibility
Ages Eligible for Study:   55 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men diagnosed with prostate cancer on or before 12/31/03 after participation in the Prostate Cancer Prevention Trial (SWOG-9217)
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00288106     History of Changes
Other Study ID Numbers: CDR0000466341  U10CA012027  S0437 
Study First Received: February 6, 2006
Last Updated: September 28, 2015
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 September 30, 2016