Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer

Localized prostate cancer can be treated in 5 sessions using a precise, targeted form of radiation known as stereotactic body radiation therapy (SBRT), with low toxicity. Despite these advances, overall outcomes for aggressive (high risk) prostate cancer remain poor, with 10-year recurrence-free survival of approximately 65% regardless of treatment modality. Recurrences are typically distant and carry poor prognosis, with 5 year survival of 25%. The investigators propose to utilize the latest advances in cancer imaging (PSMA Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MR)) and radiation delivery (MR-guided radiation therapy with real-time adaptive planning), to deliver a personalized radiation treatment that targets the areas of greatest risk of recurrence in the prostate with improved precision, and as a result improve clinical outcomes for individuals with high risk prostate cancer. PSMA PET/MR is a novel imaging modality, not yet widely available, that augments the tissue detail provided by MR. The combination of PSMA PET with MR results in improved delineation of intraprostatic nodules and higher diagnostic accuracy for detection of metastatic disease compared to conventional imaging. PSMA PET/MR imaging data is readily transferable to a MR-based linear accelerator (MR-LINAC), a novel, innovative platform that allows direct visualization of the tumor during treatment, and permits real-time individualized correction for motion with online adaptive radiation planning.

• Performance of PSMA PET/MR to MR alone at staging prostate cancer [Срок оценки: Baseline]
• Performance of PSMA PET/MR to MR alone for identification of dominant intraprostatic nodules during radiation planning [Срок оценки: Baseline]
• Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA [Срок оценки: Baseline]
• Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA [Срок оценки: 12 months]
• Change in Quality of life questionnaires (EPIC-26) will be assessed. [Срок оценки: Baseline, 1month, 6months, 12 months, 18 months and 24 months.]
• Change in The American Urological Association (AUA) symptom score [Срок оценки: Baseline, 1month, 6months, 12 months, 18 months and 24 months.]
• Change in Number of Subjects with Adverse events [Срок оценки: Baseline, 1month, 6months, 12 months and 24 months.]
• The change in radiation doses received by the surrounding normal structures/PTV for each initial and adapted plan will be analyzed with a signed-rank Wilcoxon test (non-parametric test for paired comparisons). [Срок оценки: Baseline, 1month]
• Compare the changes in the Microbiome during SBRT-SIB [Срок оценки: Baseline]
• Compare the changes in the Microbiome during SBRT-SIB [Срок оценки: approx. 3 weeks]
• Compare the changes in the Microbiome during SBRT-SIB [Срок оценки: 12 months]
• Compare the immunological changes during SBRT-SIB [Срок оценки: Baseline]