PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

Detailed Description
-----------------
PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan hot spots or areas of dose above the prescription.

Official Title
-----------------
Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation

Conditions
-----------------
Prostate Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Histologically confirmed prostate adenocarcinoma Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol. 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 Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity after Radiation | Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets | End of treatment to 1 year post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer. | Baseline to 5 years post-treatment | 
| Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition | Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes. | Baseline to 5 years post-treatment | 
| Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI) | Measuring patient-reported quality of life using EPIC-26 and PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy target volumes. | Baseline to 5 years post-treatment | 
| Screened Subjects | Measuring the proportion of screen subjects who are enrolled on the study | Through study completion, average of 2 years | 
| The feasibility of meeting dose constraints | The feasibility of meeting dose constraints will be defined as the proportion of subjects' radiotherapy treatment plan meets dose constraint criteria for PTV max, CTV, DIL, rectum, bladder, urethra, bowel, and penile bulb, as defined in the protocol. | Baseline | 
| Performance of PSMA-PET/MRI to PSMA PET/CT | Performance of PSMA-PET/MRI to PSMA PET/CT will be defined as rate of identification and delineation (e.g. sensitivity and specificity) of dominant intra-prostatic lesion in comparison to a gold standard of image-guided prostate biopsy. | Baseline | 
| Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis | Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis will be defined using PSMA-PET/MRI to PSMA PET/CT images | Baseline |