Clinical Trials /

Phase I Study MR-guided SBRT to PCa

NCT03935308

Description:

1) investigate the feasibility, tolerance, and safety of dose escalation via MR-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (DILs), 2) to assess the feasibility of DIL visualization based on multi-parametric MRI (mpMRI), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Phase I Study MR-guided SBRT to PCa
  • Official Title: Phase I Study Of MR-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost (SIB) To the Dominant Intraprostatic Lesion(s) (DILs) in Men With Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: MRgSBRT
  • NCT ID: NCT03935308

Conditions

  • Low or Intermediate Risk Prostate Cancer

Purpose

1) investigate the feasibility, tolerance, and safety of dose escalation via MR-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (DILs), 2) to assess the feasibility of DIL visualization based on multi-parametric MRI (mpMRI), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction

Trial Arms

NameTypeDescriptionInterventions
MR-guided SBRT With SIB to the DILs to Prostate CancerExperimentalDose escalation to the DIL(s) will be performed in the traditional Phase I 3+3 design. Patients will be treated in four cohorts (three patients per dose level) starting with a dose of 9 Gy to the DIL(s). If no dose limiting toxicity (DLT), defined below, is observed after 90 days, then an additional three patients will be entered at the next dose level. Dose to the DIL(s) will be escalated at 1 Gy increments until DLT is observed or if maximum dose level (60 Gy in 5 fractions of 12 Gy) is reached with no observed DLT. If one of the three patients experience a DLT at a particular dose level an additional three patients will be enrolled at that level. If two or more patients experience a DLT a lower dose level will be explored to define the maximum tolerated dose (MTD). The three patients within any cohort can be enrolled simultaneously or sequentially without any waiting period among them.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed prostate adenocarcinoma.
    
              -  Patients with low or favorable intermediate risk prostate cancer and patients with
                 unfavorable intermediate risk prostate cancer who decline androgen deprivation therapy
    
              -  Pretreatment evaluations must be completed as specified in Section 4.0
    
              -  Patients must sign a study-specific informed consent form prior to study
                 participation.
    
              -  No contraindication to MRI. For example, patients with metal fragments or implanted
                 devices such as pacemakers and aneurysm clips may not be eligible for the study
    
              -  At least one intraprostatic lesion can be identified on the mpMR images.
    
              -  Patients agree to have hydrogel placed.
    
            Exclusion Criteria:
    
              -  Patients who have a contraindication to contrast-enhanced MRI are not eligible.
                 Patients with an implanted device such as a pacemaker or metal fragments are not
                 eligible.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Determine the maximum tolerated dose to DILs until dose limiting toxicity (>=3 grade 3 GI/GU toxicity) is observed or if maximum dose level is reached
    Time Frame:2 years
    Safety Issue:
    Description:The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT

    Secondary Outcome Measures

    Measure:Quality of Life measures using the Epic questionnaire
    Time Frame:2 years
    Safety Issue:
    Description:Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Henry Ford Health System

    Trial Keywords

    • prostate cancer, MRI, intraprostatic lesions

    Last Updated

    April 30, 2019