S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

This study has been terminated.
(Poor accrual resulted in lack of feasibility to evaluate endpoints.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00288106
First received: February 6, 2006
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Prostate Cancer
Other: Follow-up

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Time to metastases [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to secondary therapy after definitive therapy [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    Definitive therapy is defined as radiotherapy or radical prostatectomy.

  • Time to PSA recurrence after definitive therapy [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    Definitive therapy is defined as radiotherapy or radical prostatectomy.

  • All cause and prostate cancer-specific mortality [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    Measured in a time-to-event analysis


Other Outcome Measures:
  • Predictive value of prognostic biomarkers [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
    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.


Enrollment: 961
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Long Term Follow-Up
Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)
Other: Follow-up
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT
Other Name: Observation

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men diagnosed with prostate cancer on or before 12/31/03 after participation in the Prostate Cancer Prevention Trial (SWOG-9217)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288106

  Hide Study Locations
Locations
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203-5400
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Dayton, Ohio, United States, 45429
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mercy Medical Center
Springfield, Ohio, United States, 45504
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oregon
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: 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
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00288106     History of Changes
Other Study ID Numbers: CDR0000466341, U10CA012027, S0437
Study First Received: February 6, 2006
Last Updated: January 2, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014