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

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00288106
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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).

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 961

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to metastases	Up to 8 years post registration

Secondary Outcome Measures

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

Trial Locations

Locations (52)

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center; 🇺🇸 Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Decatur Memorial Hospital Cancer Care Institute; 🇺🇸 Decatur, Illinois, United States

Regional Cancer Center at Memorial Medical Center; 🇺🇸 Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus; 🇺🇸 Beech Grove, Indiana, United States

Reid Hospital & Health Care Services; 🇺🇸 Richmond, Indiana, United States

Fairview Ridges Hospital; 🇺🇸 Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital; 🇺🇸 Coon Rapids, Minnesota, United States

Fairview Southdale Hospital; 🇺🇸 Edina, Minnesota, United States

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