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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00288106
• Other study ID #: CDR0000466341
• Secondary ID: U10CA012027S0437
• Status: Terminated
• Phase: N/A
• First received: February 6, 2006
• Last updated: September 28, 2015
• Start date: September 2005
• Est. completion date: May 2009

Study information

• Verified date: September 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 961
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 120 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Follow-up
No additional drug was given; clinical observation of men diagnosed with prostate cancer who were previously randomized and treated on PCPT

Locations

Country	Name	City	State
United States	Randolph Hospital	Asheboro	North Carolina
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	Mary Rutan Hospital	Bellefontaine	Ohio
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Danville Regional Medical Center	Danville	Virginia
United States	CCOP - Dayton	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Middletown Regional Hospital	Franklin	Ohio
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Oregon Health and Science University Cancer Institute	Portland	Oregon
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Reid Hospital & Health Care Services	Richmond	Indiana
United States	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Cancer Center	Saint Louis Park	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Mercy Medical Center	Springfield	Ohio
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Clinton Memorial Hospital	Wilmington	Ohio
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive value of prognostic biomarkers	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	No
Primary	Time to metastases		Up to 8 years post registration	No
Secondary	Time to secondary therapy after definitive therapy	Definitive therapy is defined as radiotherapy or radical prostatectomy.	Up to 8 years post registration	No
Secondary	Time to PSA recurrence after definitive therapy	Definitive therapy is defined as radiotherapy or radical prostatectomy.	Up to 8 years post registration	No
Secondary	All cause and prostate cancer-specific mortality	Measured in a time-to-event analysis	Up to 8 years post registration	No