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Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer


N/A
55 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to metastases

Outcome Time Frame:

Up to 8 years post registration

Safety Issue:

No

Principal Investigator

Ian M. Thompson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Federal Government

Study ID:

CDR0000466341

NCT ID:

NCT00288106

Start Date:

September 2005

Completion Date:

May 2009

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
Mercy Medical Center Springfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Danville Regional Medical Center Danville, Virginia  24541
Randolph Hospital Asheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro, North Carolina  27401
Annie Penn Cancer Center Reidsville, North Carolina  27320
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Reid Hospital & Health Care Services Richmond, Indiana  47374
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Oregon Health and Science University Cancer Institute Portland, Oregon  97239-3098