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Status:

COMPLETED

Intensity Modulated Radiation Therapy for Prostate Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18-90 years

Phase:

EARLY_PHASE1

Brief Summary

BACKGROUND: -This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-017...

Detailed Description

BACKGROUND: -This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-017...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Pathology report confirming adenocarcinoma of the prostate
  • Risk of lymph node metastasis greater than or equal to15% as defined by the Partin tables or biopsy proven positive lymph nodes
  • Tumor visible on magnetic resonance imaging (MRI)
  • No prior surgery, radiation, or chemotherapy for prostate cancer, with the exception of hormone therapy which may be given neoadjuvantly for up to four (4) months.
  • Age greater than 18 years old and less than 90 years old.
  • EXCLUSION CRITERIA:
  • Cognitively impaired patients who cannot give informed consent.
  • Patients with metastatic disease beyond the pelvis
  • Contraindication to biopsy
  • Bleeding disorder
  • Prothrombin time (PT)/partial thromboplastin time (PTT) greater than or equal to 1.5 times the upper limit of normal
  • Platelets less than or equal to 50K
  • Artificial heart valve
  • Contraindication to MRI
  • Patients weighing greater than136 kgs (weight limit for the scanner tables)
  • Allergy to magnetic resonance (MR) contrast agent
  • Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.
  • Pre-existing and active prostatitis or proctitis
  • Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.

Exclusion

    Key Trial Info

    Start Date :

    September 19 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 18 2018

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00214422

    Start Date

    September 19 2005

    End Date

    April 18 2018

    Last Update

    July 19 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892