Clinical Trials /

MRI Guided SBRT for Localized Prostate Cancer

NCT03778112

Description:

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered. In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: MRI Guided SBRT for Localized Prostate Cancer
  • Official Title: Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 15060207
  • NCT ID: NCT03778112

Conditions

  • Prostate Cancer

Purpose

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered. In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.

Detailed Description

      Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional
      RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated
      RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study
      combines the benefits of RT dose escalation while shortening the overall RT treatment course.

      In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified
      to two separate SBRT regimens depending on whether prostate lesions are present. For patients
      without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach
      will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive
      IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a
      SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB)
      (21 Gy in 3 fractions) to intraprostatic lesion(s) only.

      Patients will be regularly assessed every 3 months for the first 2 years and then every 6
      months, indefinitely. Side effects will be monitored using the standardized international
      prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at
      baseline and subsequent follow-up appointments.

      Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk
      prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor
      control without increasing toxicity, all in a shortened treatment duration.
    

Trial Arms

NameTypeDescriptionInterventions
Negative mpMRI Prostate ScanExperimentalSBRT to the whole prostate
    Positive mpMRI Prostate ScanExperimentalIMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Biopsy proven prostate adenocarcinoma within 1 year of randomization
      
                -  NCCN Low to High Risk localized prostate cancer
      
                -  Zubrod Performance Status 0-1 within 60 days prior to registration
      
              Exclusion Criteria:
      
                -  Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
      
                -  Regional Lymph Node (N1) involvement
      
                -  Distant Metastases (M1) involvement
      
                -  History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
      
                -  Prior chemotherapy
      
                -  Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease;
                   AIDS)
      
                -  Acute bacterial or fungal infection requiring IV antibiotics
      
                -  Inability to undergo MRI
      
                -  Inability to receive fiducial markers
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Rate of Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
      Time Frame:18 months
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Rate of Acute Radiation Induced Genitourinary Toxicity
      Time Frame:3 months
      Safety Issue:
      Description:
      Measure:Biochemical Recurrence
      Time Frame:18 months
      Safety Issue:
      Description:
      Measure:Disease Free-Survival
      Time Frame:18 months
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Rush University Medical Center

      Trial Keywords

      • Prostate Cancer
      • Radiotherapy
      • SBRT
      • Stereotactic Body Radiotherapy
      • MRI

      Last Updated

      December 18, 2018