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

Not Applicable

Completed

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
MR-Guided Prostate SBRT	MR-Guided Prostate SBRT	-

Primary Outcome Measures

Name	Time	Method
Change in Number of Subjects With Adverse Events Will be Collected	baseline, 3-6months and at 9-12 months.	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

Name	Time	Method
Change in Quality of Life Questionnaires Will be Assessed.	baseline, 3-6months and at 9-12 months.	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. There are 5 domains, urinary incontinence, urinary Irritative/Obstructive, Bowel, Sexual function and Hormonal. For each domain, the 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.
Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.	baseline, 3-6months and at 9-12 months.	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)