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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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Brief 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).


Condition or disease Intervention/treatment
Prostate Cancer Other: Follow-up

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.


Study Design
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Study Type : Observational
Actual Enrollment : 961 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to metastases [ Time Frame: Up to 8 years post registration ]

Secondary Outcome Measures :
  1. Time to secondary therapy after definitive therapy [ Time Frame: Up to 8 years post registration ]
    Definitive therapy is defined as radiotherapy or radical prostatectomy.

  2. Time to PSA recurrence after definitive therapy [ Time Frame: Up to 8 years post registration ]
    Definitive therapy is defined as radiotherapy or radical prostatectomy.

  3. All cause and prostate cancer-specific mortality [ Time Frame: Up to 8 years post registration ]
    Measured in a time-to-event analysis


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 120 Years   (Adult, Senior)
Sexes 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
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Information from the National Library of Medicine

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


  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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 ( U.S. NIH Grant/Contract )
S0437 ( Other Identifier: SWOG )
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

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