Clinical Trials /

PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer

NCT04220983

Description:

Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04220983

Trial Eligibility

Document

Title

  • Brief Title: PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
  • Official Title: PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 19-04020263
  • NCT ID: NCT04220983

Conditions

  • Metastatic Prostate Cancer

Purpose

Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.

Detailed Description

      The MRidian ViewRay offers delivery of prostate SBRT with real-time MR guidance, which
      provides superior soft-tissue differentiation with excellent visualization of the prostate.
      This ViewRay platform offers the ideal setting for this study, that aims at precisely
      delivering prostate SBRT with a simultaneous integrated boost (when indicated) to visible
      nodules.

      In this study, we hope to demonstrate the safety and feasibility of using 36.25 Gy in 5
      fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic
      prostate cancer.

Trial Arms

NameTypeDescriptionInterventions
MR-Guided Prostate SBRTOther

    Eligibility Criteria

            Inclusion Criteria:

          -  Biopsy-proven diagnosis of prostate adenocarcinoma

          -  Age ≥ 18

          -  Must have biopsy-proven metastatic prostate cancer

        Exclusion Criteria:

          -  History of prior pelvic radiation (external beam or brachytherapy)

          -  Inability to undergo MRI

          -  AUA score >20

          -  For patients on systemic therapy, enrollment must be within six months of start of
             therapy unless exception is made by protocol PIs.
    Maximum Eligible Age:90 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Change in Number of Subjects with Adverse events will be collected
    Time Frame:baseline, 3-6months and at 9-12 months.
    Safety Issue:
    Description:Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment.

    Secondary Outcome Measures

    Measure:Change in Quality of life questionnaires will be assessed.
    Time Frame:baseline, 3-6months and at 9-12 months.
    Safety Issue:
    Description:Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. QOL assessments will occur at baseline, 3-6 months, and at 9-12 months.
    Measure:Change in The International Prostate Symptom Score (I-PSS) will be assessed.
    Time Frame:baseline, 3-6months and at 9-12 months.
    Safety Issue:
    Description:The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicatingincreasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35)

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Weill Medical College of Cornell University

    Last Updated

    October 20, 2020