PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 68Ga-HBED-CC-PSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information Male subjects ≥ 18 years of age Histologically confirmed prostate adenocarcinoma Low or favorable intermediate risk, based on the NCCN criteria Subject has adequate performance status as defined by ECOG performance status of 0-2 Subject is willing and able to comply with the protocol as determined by the Treating Investigator Subject speaks English (quality of life instrument is validated in English) Exclusion Criteria: Contraindications for MRI Other prior or concomitant malignancies, with the exception of: non-melanoma skin cancer other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence Inflammatory bowel disease Previous transurethral resection of the prostate (TURP) or surgery of the prostate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMSA-PET/MRI<br>Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment | Drug: 68Ga-HBED-CC-PSMA<br>* Radioactive tracer used during imaging to help detect PSMA expressing tumor cells<br>* Other names: gallium Ga 68-labeled PSMA-11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline to 1 year post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Baseline to 5 years post-treatment | 
| Screened Subjects | Measuring the proportion of screened subjects who are enrolled on the study | 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. | Baseline to 5 years post-treatment |