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Surgery in Treating Patients With Prostate Cancer

1. juli 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Anniston, Alabama, Forente stater, 36207
        • Northeast Alabama Regional Medical Center
    • California
      • La Jolla, California, Forente stater, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • San Diego, California, Forente stater, 92161
        • Veterans Affairs Medical Center - San Diego
      • San Diego, California, Forente stater, 92134-3202
        • Naval Medical Center - San Diego
      • San Francisco, California, Forente stater, 94115
        • UCSF Comprehensive Cancer Center
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, Forente stater, 20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33316
        • Broward General Medical Center
      • Hollywood, Florida, Forente stater, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Miami Beach, Florida, Forente stater, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60640
        • Louis A. Weiss Memorial Hospital
      • Peoria, Illinois, Forente stater, 61615-7828
        • CCOP - Illinois Oncology Research Association
      • River Forest, Illinois, Forente stater, 60305
        • West Suburban Center for Cancer Care
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Incorporated
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40207
        • Baptist Hospital East - Louisville
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Worcester, Massachusetts, Forente stater, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Saint Joseph, Michigan, Forente stater, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198-7680
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, Forente stater, 89106
        • Veterans Affairs Medical Center - Las Vegas
    • New Hampshire
      • Hooksett, New Hampshire, Forente stater, 03106
        • New Hampshire Oncology-Hematology, PA - Hooksett
      • Lebanon, New Hampshire, Forente stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cancer Institute of New Jersey at the Cooper University Hospital
      • Paterson, New Jersey, Forente stater, 07503
        • St. Joseph's Hospital and Medical Center
    • New York
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Forente stater, 13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Elmhurst, New York, Forente stater, 11373
        • Elmhurst Hospital Center
      • Jamaica, New York, Forente stater, 11432
        • Queens Cancer Center of Queens Hospital
      • Manhasset, New York, Forente stater, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forente stater, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, Forente stater, 10029
        • Mount Sinai Medical Center
      • Syracuse, New York, Forente stater, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28805-9913
        • Veterans Affairs Medical Center - Asheville
      • Chapel Hill, North Carolina, Forente stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Concord, North Carolina, Forente stater, 28025
        • NorthEast Oncology Associates - Concord
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Fayetteville, North Carolina, Forente stater, 28302-2000
        • Cape Fear Valley Medical Center
      • Goldsboro, North Carolina, Forente stater, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
      • Kinston, North Carolina, Forente stater, 28503-1678
        • Lenoir Memorial Cancer Center
      • Pinehurst, North Carolina, Forente stater, 28374
        • Comprehensive Cancer Center at Moore Regional Hospital
      • Wilmington, North Carolina, Forente stater, 28402-9025
        • Zimmer Cancer Center at New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma University Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Miriam Hospital at Lifespan
    • Texas
      • Dallas, Texas, Forente stater, 75219
        • Veterans Affairs Medical Center - Dallas
    • Vermont
      • Burlington, Vermont, Forente stater, 05401-3498
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22902
        • Martha Jefferson Hospital
      • Norfolk, Virginia, Forente stater, 23502
        • Virginia Oncology Associates - Norfolk
      • Richmond, Virginia, Forente stater, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Roanoke, Virginia, Forente stater, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
    • West Virginia
      • Huntington, West Virginia, Forente stater, 25701
        • St. Mary's Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 75 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Surgery
Salvage prostatectomy
Fremgangsmåte: conventional surgery
Salvage prostatectomy

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Gary D. Steinberg, MD, University of Chicago

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 1997

Primær fullføring (Faktiske)

1. februar 2005

Studiet fullført (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CALGB-9687
  • U10CA031946 (U.S. NIH-stipend/kontrakt)
  • CDR0000065381 (Registeridentifikator: NCI Physician Data Query)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere