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Surgery in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven recurrent or persistent prostate cancer Prostate-specific antigen (PSA) no greater than 20 ng/mL Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL No metastatic disease at time of biopsy PATIENT CHARACTERISTICS: Age: 75 and under Performance status: CALGB (Zubrod) 0-1 Life expectancy: At least 5-10 years Other: No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Endocrine therapy: At least 3 months since prior adjuvant hormonal therapy Radiotherapy: See Disease Characteristics At least 18 months since prior external beam or interstitial radiotherapy

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Rebecca and John Moores UCSD Cancer Center
  • Naval Medical Center - San Diego
  • Veterans Affairs Medical Center - San Diego
  • UCSF Comprehensive Cancer Center
  • CCOP - Christiana Care Health Services
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Washington, DC
  • Broward General Medical Center
  • Memorial Cancer Institute at Memorial Regional Hospital
  • CCOP - Mount Sinai Medical Center
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • CCOP - Illinois Oncology Research Association
  • West Suburban Center for Cancer Care
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • Holden Comprehensive Cancer Center at University of Iowa
  • Baptist Hospital East - Louisville
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • UMASS Memorial Cancer Center - University Campus
  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - Las Vegas
  • New Hampshire Oncology-Hematology, PA - Hooksett
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Institute of New Jersey at the Cooper University Hospital
  • St. Joseph's Hospital and Medical Center
  • Roswell Park Cancer Institute
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Elmhurst Hospital Center
  • Queens Cancer Center of Queens Hospital
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Mount Sinai Medical Center
  • SUNY Upstate Medical University Hospital
  • Veterans Affairs Medical Center - Asheville
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • NorthEast Oncology Associates - Concord
  • Duke Comprehensive Cancer Center
  • Cape Fear Valley Medical Center
  • CCOP - Southeast Cancer Control Consortium
  • Lenoir Memorial Cancer Center
  • Comprehensive Cancer Center at Moore Regional Hospital
  • Zimmer Cancer Center at New Hanover Regional Medical Center
  • Comprehensive Cancer Center at Wake Forest University
  • Oklahoma University Medical Center
  • Miriam Hospital at Lifespan
  • Veterans Affairs Medical Center - Dallas
  • Vermont Cancer Center at University of Vermont
  • Martha Jefferson Hospital
  • Virginia Oncology Associates - Norfolk
  • MBCCOP - Massey Cancer Center
  • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
  • St. Mary's Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgery

Arm Description

Salvage prostatectomy

Outcomes

Primary Outcome Measures

Survival characteristics

Secondary Outcome Measures

QOL assessment
Quality of life questionnaire

Full Information

First Posted
November 1, 1999
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002938
Brief Title
Surgery in Treating Patients With Prostate Cancer
Official Title
The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Other
Arm Description
Salvage prostatectomy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Salvage prostatectomy
Primary Outcome Measure Information:
Title
Survival characteristics
Time Frame
pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
Secondary Outcome Measure Information:
Title
QOL assessment
Description
Quality of life questionnaire
Time Frame
pre treatment; 3, 6, 12, 18, and 24 mon post treatment

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent or persistent prostate cancer Prostate-specific antigen (PSA) no greater than 20 ng/mL Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL No metastatic disease at time of biopsy PATIENT CHARACTERISTICS: Age: 75 and under Performance status: CALGB (Zubrod) 0-1 Life expectancy: At least 5-10 years Other: No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Endocrine therapy: At least 3 months since prior adjuvant hormonal therapy Radiotherapy: See Disease Characteristics At least 18 months since prior external beam or interstitial radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary D. Steinberg, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Naval Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134-3202
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Baptist Hospital East - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UMASS Memorial Cancer Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
New Hampshire Oncology-Hematology, PA - Hooksett
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cancer Institute of New Jersey at the Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805-9913
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
NorthEast Oncology Associates - Concord
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Valley Medical Center
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Lenoir Memorial Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28503-1678
Country
United States
Facility Name
Comprehensive Cancer Center at Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Zimmer Cancer Center at New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402-9025
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Miriam Hospital at Lifespan
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Veterans Affairs Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Sokoloff MH, Halabi S, Sanford B, et al.: Management of recurrent prostate cancer after radiotherapy: preliminary results of CALGB 9687, a contemporary salvage prostatectomy series. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-166, 2005.
Results Reference
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Surgery in Treating Patients With Prostate Cancer

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