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

September 28, 2015 updated by: Southwest Oncology Group

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

961

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to metastases
Time Frame: Up to 8 years post registration
Up to 8 years post registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to secondary therapy after definitive therapy
Time Frame: Up to 8 years post registration
Definitive therapy is defined as radiotherapy or radical prostatectomy.
Up to 8 years post registration
Time to PSA recurrence after definitive therapy
Time Frame: Up to 8 years post registration
Definitive therapy is defined as radiotherapy or radical prostatectomy.
Up to 8 years post registration
All cause and prostate cancer-specific mortality
Time Frame: Up to 8 years post registration
Measured in a time-to-event analysis
Up to 8 years post registration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of prognostic biomarkers
Time Frame: Up to 8 years post registration
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000466341
  • U10CA012027 (U.S. NIH Grant/Contract)
  • S0437 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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