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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Weill Medical College of Cornell University
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Updated on 19 February 2024
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cancer
adenocarcinoma
MRI
stereotactic body radiation therapy
non-metastatic prostate cancer
adenocarcinoma of prostate
metastatic prostate cancer
prostate cancer

Summary

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.

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.

Details
Condition Metastatic Prostate Cancer
Age 18years - 90years
Treatment MR-Guided Prostate SBRT
Clinical Study IdentifierNCT04220983
SponsorWeill Medical College of Cornell University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Evidence of disease progression on bone scan, MR and/or CT
For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs
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cancer
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MRI
stereotactic body radiation therapy
non-metastatic prostate cancer
adenocarcinoma of prostate
metastatic prostate cancer
prostate cancer

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