Prostate MRI and Pylarify PSMA PET/CT

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

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].

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sirisha Nandular, MD; Phone Number: 248-551-5000; Email: sirisha.nandalur@beaumont.edu
• Study Contact Backup: Name: Mary G Martin, RN; Phone Number: 248-551-5000; Email: mary.martin@beaumont.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment MRIs and Pylarify PSMA PET/CTs; 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); Piflufolastat F18 will first be given intravenously over about 5 seconds.; Other Names: Pylarify

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Sirisha Nandular, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; radiation therapy; androgen deprivation therapy; PSMA PET; Pylarify; Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2022-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes