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Long-Term Follow-Up Study of Patients Who Were Diagnosed With Prostate Cancer While Undergoing Treatment on a Prostate Cancer Prevention Trial (PCPT)
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Long-Term Follow-Up Study of Patients Who Were Diagnosed With Prostate Cancer While Undergoing Treatment on a Prostate Cancer Prevention Trial
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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No phase specified
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Natural history/Epidemiology
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Active
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55 and over at time of enrollment to SWOG-9217
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NCI
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SWOG-S0437
NCT00288106, SWOG-S0437
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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.
Entry Criteria Disease Characteristics:
- Diagnosed with prostate cancer on or before December 31, 2003
- Previously randomized in the Prostate Cancer Prevention Trial SWOG-9217 to receive either finasteride or a placebo
Prior/Concurrent Therapy:
- See Disease Characteristics
Patient Characteristics:
Expected Enrollment 2397Approximately 2,397 patients will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | | Ian Thompson, MD, Protocol chair | | | | | Scott Lippman, MD, FACP, Protocol co-chair | | | | | E. David Crawford, MD, Protocol co-chair | | | |
Trial Sites
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| U.S.A. |
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| Illinois |
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Springfield |
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| | | | | | | | | Regional Cancer Center at Memorial Medical Center |
| | | Clinical Trials Office - Regional Cancer Center at Memorial Medical Center | |
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| Indiana |
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Beech Grove |
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| | | | St. Francis Hospital and Health Centers - Beech Grove Campus |
| | | Howard Gross, MD | |
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Richmond |
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| | | Reid Hospital & Health Care Services |
| | | Howard Gross, MD | |
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| Mississippi |
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Jackson |
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| | | | University of Mississippi Cancer Clinic |
| | | Charles Pound, MD | |
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| North Carolina |
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Asheboro |
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| | | | Randolph Hospital |
| | | Clinical Trails Office - Randolph Hospital | |
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Greensboro |
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| | | Moses Cone Regional Cancer Center at Wesley Long Community Hospital |
| | | Clinical Trials Office - Moses Cone Regional Cancer Center at Wesley Long Community Hospital | |
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Reidsville |
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| | | Annie Penn Cancer Center |
| | | Clinical Trials Office - Annie Penn Cancer Center | |
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| Ohio |
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Bellefontaine |
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| | | | Mary Rutan Hospital |
| | | J. Philip Kuebler, MD, PhD | |
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Chillicothe |
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| | | Adena Regional Medical Center |
| | | Clinical Trials Office - Adena Regional Medical Center | |
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Columbus |
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| | | CCOP - Columbus |
| | | J. Philip Kuebler, MD, PhD | |
| | | Doctors Hospital at Ohio Health |
| | | Clinical Trials Office - Doctors Hospital at Ohio Health | |
| | | Grant Medical Center Cancer Care |
| | | Clinical Trials Office - Grant Medical Center Cancer Care | |
| | | Mount Carmel Health - West Hospital |
| | | J. Philip Kuebler, MD, PhD | |
| | | Riverside Methodist Hospital Cancer Care |
| | | Clinical Trials Office - Riverside Methodist Hospital Cancer Care | |
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Dayton |
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| | | CCOP - Dayton |
| | | Howard Gross, MD | |
| | | Good Samaritan Hospital |
| | | Howard Gross, MD | |
| | | Grandview Hospital |
| | | Howard Gross, MD | |
| | | Samaritan North Cancer Care Center |
| | | Howard Gross, MD | |
| | | Veterans Affairs Medical Center - Dayton |
| | | Howard Gross, MD | |
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Delaware |
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| | | Grady Memorial Hospital |
| | | J. Philip Kuebler, MD, PhD | |
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Findlay |
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| | | Blanchard Valley Medical Associates |
| | | Howard Gross, MD | |
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Franklin |
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| | | Middletown Regional Hospital |
| | | Howard Gross, MD | |
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Kettering |
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| | | Charles F. Kettering Memorial Hospital |
| | | Clinical Trials Office - Charles F. Kettering Memorial Hospital | | Ph: | 937-298-3399 ext. 57556 | | |
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Lancaster |
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| | | Fairfield Medical Center |
| | | J. Philip Kuebler, MD, PhD | |
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Marietta |
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| | | Strecker Cancer Center at Marietta Memorial Hospital |
| | | J. Philip Kuebler, MD, PhD | |
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Newark |
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| | | Licking Memorial Cancer Care Program at Licking Memorial Hospital |
| | | J. Philip Kuebler, MD, PhD | |
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Springfield |
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| | | Community Hospital of Springfield and Clark County |
| | | J. Philip Kuebler, MD, PhD | |
| | | Mercy Medical Center |
| | | J. Philip Kuebler, MD, PhD | |
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Troy |
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| | | UVMC Cancer Care Center at Upper Valley Medical Center |
| | | Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center | |
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Westerville |
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| | | Mount Carmel St. Ann's Cancer Center |
| | | J. Philip Kuebler, MD, PhD | |
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Wilmington |
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| | | Clinton Memorial Hospital |
| | | Howard Gross, MD | |
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Xenia |
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| | | Ruth G. McMillan Cancer Center at Greene Memorial Hospital |
| | | Howard Gross, MD | |
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Zanesville |
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| | | Genesis - Good Samaritan Hospital |
| | | Clinical Trials Office - Genesis - Good Samaritan Hospital | |
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| Oregon |
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Portland |
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| | | | Oregon Health and Science University Cancer Institute |
| | | Clinical Trials Office - Oregon Health and Science University Cancer Institute | |
| | Email:
trials@ohsu.edu |
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| Virginia |
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Danville |
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| | | | Danville Regional Medical Center |
| | | Clinical Trials Office - Danville Regional Medical Center | |
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Related Information PDQ® clinical trial SWOG-9217
| Registry Information | | | Official Title | | Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed with Prostate Cancer | | | Trial Start Date | | 2005-09-01 | | | Trial Completion Date | | 2012-09-01 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00288106 | | | Date Submitted to PDQ | | 2005-12-12 | | | Information Last Verified | | 2008-11-19 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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