Spots Global Cancer Trial Database for S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
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Trial Identification
Brief Title: S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
Official Title: Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer
Study ID: NCT00288106
Conditions
Interventions
Study Description
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).
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
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Ian M. Thompson, MD
Affiliation: The University of Texas Health Science Center at San Antonio
Role: STUDY_CHAIR
Name: Scott M. Lippman, MD, FACP
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
Name: E. David Crawford, MD
Affiliation: University of Colorado, Denver
Role: STUDY_CHAIR
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