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Clinical Trial: Surgery in Treating Patients With Prostate Cancer
This study is currently recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent prostate cancer | Procedure: conventional surgery Procedure: surgery | Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of the Role of Salvage Prostatectomy After Radiation Failure in Patients With Prostate Cancer
Further Study Details:
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.
Eligibility
Ages Eligible for Study: up to 75 Years, Genders Eligible for Study: Both
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
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other "currently active" malignancy except nonmelanoma skin cancer
- Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
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
Surgery:
- Not specified
Location and Contact Information
Alabama
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Thomas W. Twele, MD 256-236-2549
California
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Preston Gable, MD 619-532-7303 pgable@nmcsd.med.navy.mil
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stephen L. Seagren, MD 619-543-5303
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
Alan Paul Venook, MD 800-888-8664 venook@cc.ucsf.edu
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting
Steven H. Krasnow, MD 202-745-8178 krasnow.steven@washington.va.gov
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP 202-782-5762 thomas.reid@na.amedd.army.mil
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Luis Ramon Barreras, MD, FACP 954-771-0692
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD 305-674-2625
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Atif M. Hussein, MD 954-986-6363
Illinois
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Gary D. Steinberg, MD 773-702-3080 gsteinbe@surgery.bsd.uchicago.edu
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
John L. Showel, MD 708-763-2700 doc.shoj@wsmc.org
Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Sreenivasa Rao Nattam, MD 260-484-8830 ledgar@fwmoh.com
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Gerald H. Clamon, MD 319-356-8110
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Daniel C. Scullin, MD 502-897-1166
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Martin J. Edelman, MD 410-328-2703 medelman@umm.edu
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org
Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Cynthia Bender, BA, CRA 269-985-4516 cbender@lakelandregional.org
Missouri
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nancy L. Bartlett, MD 314-362-4843
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
Chitha R. Hulugalle, MD 702-696-3000
New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting
Douglas Jay Weckstein, MD 603-622-6484 d.weckstein@nhoh.com
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Marc Stuart Ernstoff, MD 603-650-5534 Marc.S.Ernstoff@Hitchcock.org
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
Edison Catalano, MD 856-342-2506
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, 07503, United States; Recruiting
Arnold D. Rubin, MD 973-754-2432
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Vincent P. Vinciguerra, MD 516-562-8954
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
Elmhurst Hospital Center, Elmhurst, New York, 11373, United States; Recruiting
Vladimir Benisovich, MD 718-334-3723 beniso@aol.com
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Clifford A. Hudis, MD 212-639-6483
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Scott Wadler, MD 212-746-2844 scw2004@med.cornell.edu
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Daniel R. Budman, MD 516-562-8958
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Hans W. Grunwald, MD 718-883-4118 hans.grunwald@mssm.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Ellis G. Levine, MD 716-845-8547
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-464-8200 grazians@upstate.edu
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
Kamal M. Bakri, MD 910-609-6910
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Ellen M. Willard, MD 910-295-9205
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
David Duane Hurd, MD 336-716-2088 dhurd@wfubmc.edu
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Jeffrey Crawford, MD 919-684-5621 crawf006@mc.duke.edu
Lenoir Memorial Cancer Center, Kinston, North Carolina, 28503-1678, United States; Recruiting
Peter R. Watson, MD 252-559-2200 ext. 201
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
Thomas C. Shea, MD 919-966-7746 sheaT@med.unc.edu
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
James Grier Wall, MD 704-783-1370 jwall@northeastmedical.org
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
John C. Lucke, MD 828-299-2540
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Cyrus A. Kotwall, MD 910-763-4630
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Daniel J. Culkin, MD, FACS 405-271-6900 daniel-culkin@ouhsc.edu
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
William M. Sikov, MD 401-793-7151 wsikov@lifespan.org
Texas
Veterans Affairs Medical Center - Dallas, Dallas, Texas, 75219, United States; Recruiting
Jonathan Dowell, MD 214-857-0737
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Hyman Bernard Muss, MD 802-847-3827
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
Stefan M. Gorsch, MD 434-982-8410
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
John D. Roberts, MD 804-828-0450
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Paul D. Richards, MD 540-982-0237 paul.richards@usoncology.com
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Paul R. Conkling, MD 757-466-8683
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
Gerrit A. Kimmey, MD 304-528-4645
Study chairs or principal investigators
Gary D. Steinberg, MD, Study Chair, University of Chicago Cancer Research Center
Joseph W. Basler, PhD, MD, Study Chair, University of Texas
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000065381; CALGB-9687; SWOG-C9687; NCT00002938
Record last reviewed: September 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002938
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: September 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002938
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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