The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.
This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells
Genitourinary and gastrointestinal toxicity 12 months post-treatment
Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
Time frame: Baseline to 1 year post-treatment
Feasibility of meeting specified dose constraints
Proportion of subjects who meet these criteria: * Boost dose coverage: DIL D95% ≥ 44 Gy * Dose constraints: Urethra Dmax \< 40 Gy Bladder Dmax \< 45.6 Gy Bladder D10cc \< 41.8 Gy Rectum Dmax \< 38 Gy Rectal Mucosa D1% \< 28.5 Gy Sigmoid Colon Dmax \< 28.5 Gy
Time frame: Baseline to 1 year post-treatment
Acute and late genitourinary and gastrointestinal toxicity
GU and GI toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Will be measured during radiation therapy and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after radiotherapy.
Time frame: Baseline to 5 years post-treatment
Biochemical control using Prostate-Specific Antigen (PSA) levels
Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy
Time frame: Baseline to 5 years post-treatment
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)
Measuring patient-reported quality of life using EPIC-26 prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Time frame: Baseline to 5 years post-treatment
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Screened Subjects
Measuring the proportion of screened subjects who are enrolled on the study
Time frame: Through study completion, average of 2 years
Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)
Measuring patient-reported quality of life using PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Time frame: Baseline to 5 years post-treatment