S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
NCT ID: NCT00288106
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
961 participants
OBSERVATIONAL
2005-09-30
2009-05-31
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Long Term Follow-Up
Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)
Follow-up
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Interventions
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Follow-up
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with prostate cancer on or before December 31, 2003
DISEASE CHARACTERISTICS:
* Diagnosed by either study site or central pathology review
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
* Not Applicable
55 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Ian M. Thompson, MD
Role: STUDY_CHAIR
The University of Texas Health Science Center at San Antonio
Scott M. Lippman, MD, FACP
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
E. David Crawford, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Locations
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Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Reid Hospital & Health Care Services
Richmond, Indiana, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Randolph Hospital
Asheboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Annie Penn Cancer Center
Reidsville, North Carolina, United States
Mary Rutan Hospital
Bellefontaine, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States
Danville Regional Medical Center
Danville, Virginia, United States
Countries
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References
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Chau CH, Price DK, Till C, Goodman PJ, Chen X, Leach RJ, Johnson-Pais TL, Hsing AW, Hoque A, Tangen CM, Chu L, Parnes HL, Schenk JM, Reichardt JK, Thompson IM, Figg WD. Finasteride concentrations and prostate cancer risk: results from the Prostate Cancer Prevention Trial. PLoS One. 2015 May 8;10(5):e0126672. doi: 10.1371/journal.pone.0126672. eCollection 2015.
Other Identifiers
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S0437
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000466341
Identifier Type: -
Identifier Source: org_study_id
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