- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288106
S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer
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).
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Jupiter, Florida, United States, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Springfield, Illinois, United States, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Indiana
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Beech Grove, Indiana, United States, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Richmond, Indiana, United States, 47374
- Reid Hospital & Health Care Services
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Minnesota
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, United States, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, United States, 55102
- United Hospital
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Shakopee, Minnesota, United States, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Cancer Clinic
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North Carolina
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Asheboro, North Carolina, United States, 27203-5400
- Randolph Hospital
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Greensboro, North Carolina, United States, 27403-1198
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
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Reidsville, North Carolina, United States, 27320
- Annie Penn Cancer Center
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Ohio
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Bellefontaine, Ohio, United States, 43311
- Mary Rutan Hospital
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Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
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Columbus, Ohio, United States, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, United States, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, United States, 43215
- CCOP - Columbus
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Columbus, Ohio, United States, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, United States, 43228
- Doctors Hospital at Ohio Health
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, United States, 45405
- Grandview Hospital
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Dayton, Ohio, United States, 45406
- Good Samaritan Hospital
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Dayton, Ohio, United States, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, United States, 45429
- CCOP - Dayton
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Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
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Findlay, Ohio, United States, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, United States, 45005-1066
- Middletown Regional Hospital
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Kettering, Ohio, United States, 45429
- Charles F. Kettering Memorial Hospital
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Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
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Marietta, Ohio, United States, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Newark, Ohio, United States, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Springfield, Ohio, United States, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, United States, 45504
- Mercy Medical Center
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Troy, Ohio, United States, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Westerville, Ohio, United States, 43081
- Mount Carmel St. Ann's Cancer Center
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Wilmington, Ohio, United States, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, United States, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Zanesville, Ohio, United States, 43701
- Genesis - Good Samaritan Hospital
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health and Science University Cancer Institute
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Virginia
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Danville, Virginia, United States, 24541
- Danville Regional Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- Not Applicable
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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)
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No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to metastases
Time Frame: Up to 8 years post registration
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Up to 8 years post registration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to secondary therapy after definitive therapy
Time Frame: Up to 8 years post registration
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Definitive therapy is defined as radiotherapy or radical prostatectomy.
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Up to 8 years post registration
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Time to PSA recurrence after definitive therapy
Time Frame: Up to 8 years post registration
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Definitive therapy is defined as radiotherapy or radical prostatectomy.
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Up to 8 years post registration
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All cause and prostate cancer-specific mortality
Time Frame: Up to 8 years post registration
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Measured in a time-to-event analysis
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Up to 8 years post registration
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive value of prognostic biomarkers
Time Frame: Up to 8 years post registration
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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.
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Up to 8 years post registration
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Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000466341
- U10CA012027 (U.S. NIH Grant/Contract)
- S0437 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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