Surgery in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: conventional surgery
- Registration Number
- NCT00002938
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy.
PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy.
- Detailed Description
OBJECTIVES:
* Determine the characteristics of failure-free survival, disease-free survival, overall survival, surgical morbidity and mortality, and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer.
* Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy.
* Determine the quality of life measures in these patients.
* Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study.
* Determine the histologic and morphometric characterization of the carcinoma.
OUTLINE: Patients undergo modified bilateral pelvic lymph node dissection.
Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach. Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator.
Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan, or for a consistently rising prostate-specific antigen. Adjuvant hormonal therapy is also allowed.
Quality of life is assessed prior to surgery and at 3, 6, 12, 18, and 24 months after surgery.
Patients are followed at least every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgery conventional surgery Salvage prostatectomy
- Primary Outcome Measures
Name Time Method Survival characteristics pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
- Secondary Outcome Measures
Name Time Method QOL assessment pre treatment; 3, 6, 12, 18, and 24 mon post treatment Quality of life questionnaire
Trial Locations
- Locations (61)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Cancer Institute of New Jersey at the Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Miriam Hospital at Lifespan
🇺🇸Providence, Rhode Island, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸East Syracuse, New York, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Comprehensive Cancer Center at Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
NorthEast Oncology Associates - Concord
🇺🇸Concord, North Carolina, United States
Cape Fear Valley Medical Center
🇺🇸Fayetteville, North Carolina, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
🇺🇸Roanoke, Virginia, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States