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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA012027 | U.S. NIH Grant/Contract | View source | |
| S0437 | Other Identifier | SWOG |
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Poor accrual resulted in lack of feasibility to evaluate endpoints.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long Term Follow-Up | Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up | Other | No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to metastases | Up to 8 years post registration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to secondary therapy after definitive therapy | Definitive therapy is defined as radiotherapy or radical prostatectomy. | Up to 8 years post registration |
| Time to PSA recurrence after definitive therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of prognostic biomarkers | 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. | Up to 8 years post registration |
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Men diagnosed with prostate cancer on or before 12/31/03 after participation in the Prostate Cancer Prevention Trial (SWOG-9217)
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25955319 | Derived | 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. |
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|
Definitive therapy is defined as radiotherapy or radical prostatectomy.
| Up to 8 years post registration |
| All cause and prostate cancer-specific mortality | Measured in a time-to-event analysis | Up to 8 years post registration |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center |
| Jupiter |
| Florida |
| 33458 |
| United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203-5400 | United States |
| Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | 27403-1198 | United States |
| Annie Penn Cancer Center | Reidsville | North Carolina | 27320 | United States |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Mercy Medical Center | Springfield | Ohio | 45504 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Oregon Health and Science University Cancer Institute | Portland | Oregon | 97239-3098 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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