PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Prostate Cancer
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change in Number of Subjects With Adverse Events Will be Collected
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biopsy-proven diagnosis of prostate adenocarcinoma
- •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.
Outcomes
Primary Outcomes
Change in Number of Subjects With Adverse Events Will be Collected
Time Frame: 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 Outcomes
- Change in Quality of Life Questionnaires Will be Assessed.(baseline, 3-6months 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.)