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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 CenterMiami Beach, Florida  33140
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
Mercy Medical CenterSpringfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Danville Regional Medical CenterDanville, Virginia  24541
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Clinton Memorial HospitalWilmington, Ohio  45177
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Oregon Health and Science University Cancer InstitutePortland, Oregon  97239-3098