Prostate MRI and Pylarify PSMA PET/CT

Study Overview
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Brief Summary
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This is a voluntary research study to find out how using technology including advanced magnetic resonance imaging (MRI) and prostate-specific membrane antigen - positron emission tomography (PSMA-PET) scan imaging, in addition to combined prostate treatment using radiation therapy, brachytherapy (internal radiation treatment using small radioactive seeds placed inside the body) and androgen deprivation therapy (drug therapy to suppress hormones) can help doctors see, track and predict tumor response to treatment for prostate cancer patients. Participation in this study will consist of radiation planning and simulation, magnetic resonance imaging (MRI) and positron emission tomography and computed tomography scan (PET/CT). One MRI and PSMA PET/CT scan will be done prior to the start of first external beam radiation therapy (EBRT) fraction. At mid-treatment prior to the second brachytherapy fraction, an MRI and PSMA PET/CT will be done. A third scan will be performed after 75% testosterone recovery or 12 months post androgen deprivation therapy (ADT) [whichever comes first].

Detailed Description
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The goal of the study is to better understand how an individual tumor responds to radiation therapy and determine if advanced imaging can be used for prognostic purposes, especially to predict areas of local resistance and failure. The study population are patients with high risk prostate malignancy treated with a combination of external beam radiation therapy (EBRT)/brachytherapy (BT) and androgen deprivation therapy (ADT). Patients enrolled in this trial will undergo a pre-treatment MRI and PSMA PET/CT prior to the initiation of ADT and the first EBRT fraction, a mid-treatment MRI and PSMA PET/CT prior to second brachytherapy fraction, and a third MRI and PSMA PET/CT will be performed after 75% testosterone recovery or 12 months post-ADT (whichever comes first). The pre-treatment MRI and PSMA PET/CT is part of standard of care for prostate cancer workup, however all additional MRI and PSMA PET/CT mid-treatment or after treatment completion are additional research scans.

Official Title
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Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Planned definitive radiation for high-risk prostate cancer, radiotherapy plan to include high dose-rate (HDR) brachytherapy boost High-risk prostate cancer (tumor stage cT3a-cT4, OR Grade Group 4 or 5, OR prostate-specific antigen (PSA) >20 ng/mL) Patients with clinically positive regional lymph nodes Patient planned to receive at least 12 months of androgen deprivation therapy Age ≥18 years No maximum age cutoff, however must have life expectancy > 5 years based on patient's overall health Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Patient able to have 3-Tesla (3T) MRI per Beaumont Radiation Oncology MRI safety questionnaire Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status 3-5 Metastatic disease Prior androgen deprivation therapy before study enrollment Prior radiation to pelvis Prior malignancy not achieving remission or with prognosis < 5 years Synchronous malignancy confirmed or suspected Any patient not suitable for brachytherapy Severe claustrophobia precluding the acquisition of MRI Unable to safely have 3T MRI Cognitively impaired

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
Interventional Model Description: Non-randomized, prospective, single-institution
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment MRIs and Pylarify PSMA PET/CTs<br>2 MRIs and 2 Pylarify PSMA PET/CTs, occurring at mid-treatment and when testosterone level is 75% recovered or 12 months after androgen deprivation therapy (ADT), whichever comes first | Drug: Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)<br>* Piflufolastat F18 will first be given intravenously over about 5 seconds.<br>* Other names: Pylarify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference from baseline (pre-treatment) to mid-treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment | Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient. | From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment | 
| Difference from baseline (pre-treatment) to end of treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment | Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and end-of-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient. | From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy. | 
| Difference from baseline (pre-treatment) to mid-treatment scans for each patient in PSMA PET/CT | Difference in tumor voxel standard uptake value (SUV) between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient. | From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment | 
| Difference from baseline (pre-treatment) to end-of-treatment scans for each patient in PSMA PET/CT | Difference in tumor voxel standard uptake value (SUV) between pretreatment scan and end-of-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient. | From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, PSMA PET, Pylarify, androgen deprivation therapy, radiation therapy, Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)