Long-Term Follow-Up Study of Patients Who Were Diagnosed With Prostate Cancer While Undergoing Treatment on a Prostate Cancer Prevention Trial

Condition(s) targeted: Prostate Cancer

Intervention: observation (Procedure); quality-of-life assessment (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Ian M. Thompson, MD, Study Chair, Affiliation: University of Texas
Scott M. Lippman, MD, FACP, Affiliation: M.D. Anderson Cancer Center
E. David Crawford, MD, Affiliation: University of Colorado at Denver and Health Sciences Center

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).

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

Study design: N/A

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: Approximately 2,397 patients will be accrued for this study.

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosed with prostate cancer on or before December 31, 2003

- Previously randomized in the Prostate Cancer Prevention Trial SWOG-9217 to receive

either finasteride or a placebo

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD, Phone: 305-535-3310

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida 33458, United States; Recruiting
Clinical Trials Office - Ella Milbank Foshay Cancer Center, Phone: 561-745-5768

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States; Recruiting
Clinical Trials Office - Michael and Dianne Bienes Comprehensi, Phone: 954-776-3239

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States; Recruiting
Clinical Trials Office - Decatur Memorial Hospital Cancer Care, Phone: 217-876-6601

Regional Cancer Center at Memorial Medical Center, Springfield, Illinois 62781-0001, United States; Recruiting
Clinical Trials Office - Regional Cancer Center at Memorial Me, Phone: 217-788-4233

Reid Hospital & Health Care Services, Richmond, Indiana 47374, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana 46107, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216, United States; Recruiting
Charles R. Pound, MD, Phone: 601-984-5185

Annie Penn Cancer Center, Reidsville, North Carolina 27320, United States; Recruiting
Clinical Trials Office - Annie Penn Cancer Center, Phone: 336-621-8374

Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina 27403-1198, United States; Recruiting
Clinical Trials Office - Moses Cone Regional Cancer Center at, Phone: 336-621-8374

Randolph Hospital, Asheboro, North Carolina 27203-5400, United States; Recruiting
Clinical Trails Office - Randolph Hospital, Phone: 336-832-0821

Adena Regional Medical Center, Chillicothe, Ohio 45601, United States; Recruiting
Clinical Trials Office - Adena Regional Medical Center, Phone: 877-779-7585

Blanchard Valley Medical Associates, Findlay, Ohio 45840, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

CCOP - Columbus, Columbus, Ohio 43215, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

CCOP - Dayton, Dayton, Ohio 45429, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Charles F. Kettering Memorial Hospital, Kettering, Ohio 45429, United States; Recruiting
Clinical Trials Office - Charles F. Kettering Memorial Hospita, Phone: 937-298-3399 ext. 57556

Clinton Memorial Hospital, Wilmington, Ohio 45177, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Community Hospital of Springfield and Clark County, Springfield, Ohio 45505, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Doctors Hospital at Ohio Health, Columbus, Ohio 43228, United States; Recruiting
Clinical Trials Office - Doctors Hospital at Ohio Health, Phone: 614-566-3275

Fairfield Medical Center, Lancaster, Ohio 43130, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Genesis - Good Samaritan Hospital, Zanesville, Ohio 43701, United States; Recruiting
Clinical Trials Office - Genesis - Good Samaritan Hospital, Phone: 740-454-5232

Good Samaritan Hospital, Dayton, Ohio 45406, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Grady Memorial Hospital, Delaware, Ohio 43015, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Grandview Hospital, Dayton, Ohio 45405, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Grant Medical Center Cancer Care, Columbus, Ohio 43215, United States; Recruiting
Clinical Trials Office - Grant Medical Center Cancer Care, Phone: 614-566-4475

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio 43055, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Mary Rutan Hospital, Bellefontaine, Ohio 43311, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Mercy Medical Center, Springfield, Ohio 45504, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Middletown Regional Hospital, Franklin, Ohio 45005-1066, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Mount Carmel St. Ann's Cancer Center, Westerville, Ohio 43081, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States; Recruiting
Clinical Trials Office - Riverside Methodist Hospital Cancer C, Phone: 614-566-4475

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio 45385, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Samaritan North Cancer Care Center, Dayton, Ohio 45415, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio 45750, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-442-3130

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio 45373-1300, United States; Recruiting
Clinical Trials Office - UVMC Cancer Care Center at Upper Vall, Phone: 937-440-4842

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States; Recruiting
Howard M. Gross, MD, Phone: 937-832-1093

Oregon Health and Science University Cancer Institute, Portland, Oregon 97239-3098, United States; Recruiting
Clinical Trials Office - Oregon Health and Science University, Phone: 503-494-1080, Email: trials@ohsu.edu

Danville Regional Medical Center, Danville, Virginia 24541, United States; Recruiting
Clinical Trials Office - Danville Regional Medical Center, Phone: 434-799-3753

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2005
Last updated: February 11, 2009