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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:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00288106
First received: February 6, 2006
Last updated: September 28, 2015
Last verified: September 2015
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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:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Time to metastases [ Time Frame: Up to 8 years post registration ]
Secondary Outcome Measures:
- Time to secondary therapy after definitive therapy [ Time Frame: Up to 8 years post registration ]Definitive therapy is defined as radiotherapy or radical prostatectomy.
- Time to PSA recurrence after definitive therapy [ Time Frame: Up to 8 years post registration ]Definitive therapy is defined as radiotherapy or radical prostatectomy.
- All cause and prostate cancer-specific mortality [ Time Frame: Up to 8 years post registration ]Measured in a time-to-event analysis
Other Outcome Measures:
- 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.
| 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 to 120 Years (Adult, Senior) |
| Sexes 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:
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00288106
Show 52 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288106
Show 52 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00288106 History of Changes |
| Other Study ID Numbers: |
CDR0000466341 U10CA012027 ( US NIH Grant/Contract Award Number ) S0437 ( Other Identifier: SWOG ) |
| Study First Received: | February 6, 2006 |
| Last Updated: | September 28, 2015 |
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 June 23, 2017