Clinical Trials /

High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

NCT02177292

Description:

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
  • Official Title: A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: Prostate Cancer
  • NCT ID: NCT02177292

Conditions

  • Prostate Cancer

Purpose

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Detailed Description

      In this study the treating physicians will deliver a high dose of radiation to pelvic lymph
      nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost
      (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the
      response of the cancer and side effects of radiation to pelvic lymph nodes and to the
      prostate.

      It is hoped that these newer technologies will:

        1. allow a higher daily dose of radiation to the tumor and pelvic nodes

        2. avoid nearby normal tissue and organs like the rectum and bladder

        3. prevent the cancer from spreading or coming back
    

Trial Arms

NameTypeDescriptionInterventions
IMRT & IGRT Radiation TherapyExperimentalIn this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed, adenocarcinoma of the prostate
    
              -  T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA)
                 + (Gleason Score - 6)x10], or any T3-4N0M0
    
              -  Karnofsky Performance Scale > 70 (Appendix II).
    
              -  Prostate tumor biopsy grading by Gleason score classification is mandatory prior to
                 registration (Appendix V).
    
              -  No prior pelvic or prostate radiation or chemotherapy for any reason; induction
                 hormonal therapy prior to registration is acceptable.
    
              -  Patients must sign a study-specific consent form prior to registration.
    
              -  No evidence of distant metastases (Bone scanning)
    
            Exclusion Criteria:
    
              -  Clinical or pathological evidence of distant metastases (M1).
    
              -  Radical surgery for carcinoma of the prostate
    
              -  History of prior chemotherapy
    
              -  History of prior pelvic radiation therapy
    
              -  Children (age < 18).
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Biochemical control
    Time Frame:3 years after registration of the last subject.
    Safety Issue:
    Description:The primary goal of this study is to evaluate biochemical control assessed by PSA level.

    Secondary Outcome Measures

    Measure:Incidence of adverse events as assessed by Common Toxicity Criteria of Adverse Events.
    Time Frame:3 years after registration of the last subject.
    Safety Issue:
    Description:The time to the occurrence of severe late GU/GI toxicity is defined as the time interval from the tenth month after start of protocol treatment to the date of death.
    Measure:Metastasis free survival
    Time Frame:3 years after registration of the last subject.
    Safety Issue:
    Description:Metastasis free survival in patients receiving dose escalation IG-IMRT (image-guided IMRT) to the pelvic lymph nodes with a simultaneous integrated boost to the prostate.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Medical College of Wisconsin

    Last Updated

    February 1, 2017