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Prostate MRI and Pylarify PSMA PET/CT

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring MRI, PSMA PET, Pylarify, androgen deprivation therapy, radiation therapy, Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment MRIs and Pylarify PSMA PET/CTs

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    October 18, 2023
    Sponsor
    William Beaumont Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05568537
    Brief Title
    Prostate MRI and Pylarify PSMA PET/CT
    Official Title
    Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    William Beaumont Hospitals

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    MRI, PSMA PET, Pylarify, androgen deprivation therapy, radiation therapy, Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Model Description
    Non-randomized, prospective, single-institution
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment MRIs and Pylarify PSMA PET/CTs
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
    Other Intervention Name(s)
    Pylarify
    Intervention Description
    Piflufolastat F18 will first be given intravenously over about 5 seconds.
    Primary Outcome Measure Information:
    Title
    Difference from baseline (pre-treatment) to mid-treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
    Description
    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.
    Time Frame
    From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
    Title
    Difference from baseline (pre-treatment) to end of treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
    Description
    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.
    Time Frame
    From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy.
    Title
    Difference from baseline (pre-treatment) to mid-treatment scans for each patient in PSMA PET/CT
    Description
    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.
    Time Frame
    From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
    Title
    Difference from baseline (pre-treatment) to end-of-treatment scans for each patient in PSMA PET/CT
    Description
    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.
    Time Frame
    From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sirisha Nandular, MD
    Phone
    248-551-5000
    Email
    sirisha.nandalur@beaumont.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mary G Martin, RN
    Phone
    248-551-5000
    Email
    mary.martin@beaumont.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sirisha Nandular, MD
    Organizational Affiliation
    William Beaumont Hospitals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Prostate MRI and Pylarify PSMA PET/CT

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