Surgery in Treating Patients With Prostate Cancer
1. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
49
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Anniston, Alabama, Forenede Stater, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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San Diego, California, Forenede Stater, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, Forenede Stater, 92134-3202
- Naval Medical Center - San Diego
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San Francisco, California, Forenede Stater, 94115
- UCSF Comprehensive Cancer Center
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, Forenede Stater, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
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Miami Beach, Florida, Forenede Stater, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forenede Stater, 60640
- Louis A. Weiss Memorial Hospital
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Peoria, Illinois, Forenede Stater, 61615-7828
- CCOP - Illinois Oncology Research Association
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River Forest, Illinois, Forenede Stater, 60305
- West Suburban Center for Cancer Care
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, Forenede Stater, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Saint Joseph, Michigan, Forenede Stater, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Forenede Stater, 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, Forenede Stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, Forenede Stater, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Hooksett, New Hampshire, Forenede Stater, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Lebanon, New Hampshire, Forenede Stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cancer Institute of New Jersey at the Cooper University Hospital
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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New York
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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East Syracuse, New York, Forenede Stater, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Elmhurst, New York, Forenede Stater, 11373
- Elmhurst Hospital Center
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Jamaica, New York, Forenede Stater, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Forenede Stater, 10029
- Mount Sinai Medical Center
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28805-9913
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, Forenede Stater, 28025
- NorthEast Oncology Associates - Concord
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, Forenede Stater, 28302-2000
- Cape Fear Valley Medical Center
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Goldsboro, North Carolina, Forenede Stater, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Kinston, North Carolina, Forenede Stater, 28503-1678
- Lenoir Memorial Cancer Center
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Pinehurst, North Carolina, Forenede Stater, 28374
- Comprehensive Cancer Center at Moore Regional Hospital
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Wilmington, North Carolina, Forenede Stater, 28402-9025
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Medical Center
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02906
- Miriam Hospital at Lifespan
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Texas
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Dallas, Texas, Forenede Stater, 75219
- Veterans Affairs Medical Center - Dallas
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Vermont
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Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, Forenede Stater, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, Forenede Stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, Forenede Stater, 24014
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- St. Mary's Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 75 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Surgery
Salvage prostatectomy
|
Salvage prostatectomy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Survival characteristics
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
QOL assessment
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Gary D. Steinberg, MD, University of Chicago
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 1997
Primær færdiggørelse (Faktiske)
1. februar 2005
Studieafslutning (Faktiske)
1. januar 2010
Datoer for studieregistrering
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CALGB-9687
- U10CA031946 (U.S. NIH-bevilling/kontrakt)
- CDR0000065381 (Registry Identifier: NCI Physician Data Query)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .