PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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