Surgery in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Cancer and Leukemia Group B
Collaborators:
Southwest Oncology Group
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00002938
First received: November 1, 1999
Last updated: March 15, 2012
Last verified: March 2011
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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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: conventional surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial |
Resource links provided by NLM:
Further study details as provided by Cancer and Leukemia Group B:
Primary Outcome Measures:
- Survival characteristics [ Time Frame: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- QOL assessment [ Time Frame: pre treatment; 3, 6, 12, 18, and 24 mon post treatment ] [ Designated as safety issue: No ]Quality of life questionnaire
| Enrollment: | 49 |
| Study Start Date: | May 1997 |
| Estimated Study Completion Date: | March 2016 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Surgery
Salvage prostatectomy
|
Procedure: conventional surgery
Salvage prostatectomy
|
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 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:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002938
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Hide Study LocationsLocations
| United States, Alabama | |
| Northeast Alabama Regional Medical Center | |
| Anniston, Alabama, United States, 36207 | |
| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Naval Medical Center - San Diego | |
| San Diego, California, United States, 92134-3202 | |
| Veterans Affairs Medical Center - San Diego | |
| San Diego, California, United States, 92161 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Veterans Affairs Medical Center - Washington, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| Broward General Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Memorial Cancer Institute at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615-7828 | |
| West Suburban Center for Cancer Care | |
| River Forest, Illinois, United States, 60305 | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kentucky | |
| Baptist Hospital East - Louisville | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| Veterans Affairs Medical Center - Las Vegas | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| New Hampshire Oncology-Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at the Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| East Syracuse, New York, United States, 13057 | |
| Elmhurst Hospital Center | |
| Elmhurst, New York, United States, 11373 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Veterans Affairs Medical Center - Asheville | |
| Asheville, North Carolina, United States, 28805-9913 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| NorthEast Oncology Associates - Concord | |
| Concord, North Carolina, United States, 28025 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Cape Fear Valley Medical Center | |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Lenoir Memorial Cancer Center | |
| Kinston, North Carolina, United States, 28503-1678 | |
| Comprehensive Cancer Center at Moore Regional Hospital | |
| Pinehurst, North Carolina, United States, 28374 | |
| Zimmer Cancer Center at New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28402-9025 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Rhode Island | |
| Miriam Hospital at Lifespan | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Veterans Affairs Medical Center - Dallas | |
| Dallas, Texas, United States, 75219 | |
| United States, Vermont | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Martha Jefferson Hospital | |
| Charlottesville, Virginia, United States, 22902 | |
| Virginia Oncology Associates - Norfolk | |
| Norfolk, Virginia, United States, 23502 | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | |
| Roanoke, Virginia, United States, 24014 | |
| United States, West Virginia | |
| St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25701 | |
Sponsors and Collaborators
Cancer and Leukemia Group B
Southwest Oncology Group
Investigators
| Study Chair: | Gary D. Steinberg, MD | University of Chicago |
| Study Chair: | Joseph W. Basler, MD, PhD | University of Texas Health Science Center at San Antonio |
More Information
Additional Information:
Publications:
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.
| Responsible Party: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00002938 History of Changes |
| Other Study ID Numbers: | CDR0000065381, U10CA031946, CALGB-9687, SWOG-C9687 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013