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

February 6, 2006
January 2, 2013
September 2005
May 2009   (final data collection date for primary outcome measure)
Time to metastases [ Time Frame: Up to 8 years post registration ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00288106 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
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.
Not Provided
 
S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Prostate Cancer
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
Long Term Follow-Up
Follow-up data collection study for men who developed prostate cancer after participation in SWOG-9217 (PCPT)
Intervention: Other: Follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
961
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Male
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00288106
CDR0000466341, U10CA012027, S0437
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
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
Southwest Oncology Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP