- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00002938
Surgery in Treating Patients With Prostate Cancer
The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, Estados Unidos, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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San Diego, California, Estados Unidos, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, Estados Unidos, 92134-3202
- Naval Medical Center - San Diego
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San Francisco, California, Estados Unidos, 94115
- UCSF Comprehensive Cancer Center
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, Estados Unidos, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Miami Beach, Florida, Estados Unidos, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60640
- Louis A. Weiss Memorial Hospital
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Peoria, Illinois, Estados Unidos, 61615-7828
- CCOP - Illinois Oncology Research Association
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River Forest, Illinois, Estados Unidos, 60305
- West Suburban Center for Cancer Care
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Saint Joseph, Michigan, Estados Unidos, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-7680
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, Estados Unidos, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Hooksett, New Hampshire, Estados Unidos, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cancer Institute of New Jersey at the Cooper University Hospital
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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East Syracuse, New York, Estados Unidos, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Elmhurst, New York, Estados Unidos, 11373
- Elmhurst Hospital Center
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Jamaica, New York, Estados Unidos, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, Estados Unidos, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Estados Unidos, 11030
- North Shore University Hospital
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28805-9913
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, Estados Unidos, 28025
- NorthEast Oncology Associates - Concord
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, Estados Unidos, 28302-2000
- Cape Fear Valley Medical Center
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Goldsboro, North Carolina, Estados Unidos, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Kinston, North Carolina, Estados Unidos, 28503-1678
- Lenoir Memorial Cancer Center
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Pinehurst, North Carolina, Estados Unidos, 28374
- Comprehensive Cancer Center at Moore Regional Hospital
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Wilmington, North Carolina, Estados Unidos, 28402-9025
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma University Medical Center
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Miriam Hospital at Lifespan
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Texas
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Dallas, Texas, Estados Unidos, 75219
- Veterans Affairs Medical Center - Dallas
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Vermont
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Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, Estados Unidos, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, Estados Unidos, 24014
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- St. Mary's Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Surgery
Salvage prostatectomy
|
Salvage prostatectomy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Survival characteristics
Periodo de tiempo: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
|
pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
QOL assessment
Periodo de tiempo: pre treatment; 3, 6, 12, 18, and 24 mon post treatment
|
Quality of life questionnaire
|
pre treatment; 3, 6, 12, 18, and 24 mon post treatment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Gary D. Steinberg, MD, University of Chicago
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CALGB-9687
- U10CA031946 (Subvención/contrato del NIH de EE. UU.)
- CDR0000065381 (Identificador de registro: NCI Physician Data Query)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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