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Prostate MRI and Pylarify PSMA PET/CT

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ClinicalTrials.gov Identifier: NCT05568537
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Sirisha Nandalur, MD, William Beaumont Hospitals

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].

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Pylarify Piflufolastat Flourine-18 (18F-DCFPyL) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized, prospective, single-institution
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Pylarify




Primary Outcome Measures :
  1. Difference from baseline (pre-treatment) to mid-treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment [ Time Frame: From start of treatment to before brachytherapy dose number 2, approximately day 15 of 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.

  2. Difference from baseline (pre-treatment) to end of treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment [ Time Frame: From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy. ]
    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.

  3. Difference from baseline (pre-treatment) to mid-treatment scans for each patient in PSMA PET/CT [ Time Frame: From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment ]
    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.

  4. Difference from baseline (pre-treatment) to end-of-treatment scans for each patient in PSMA PET/CT [ Time Frame: From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568537


Contacts
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Contact: Sirisha Nandular, MD 248-551-5000 sirisha.nandalur@beaumont.edu
Contact: Mary G Martin, RN 248-551-5000 mary.martin@beaumont.org

Sponsors and Collaborators
Sirisha Nandalur, MD
Investigators
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Principal Investigator: Sirisha Nandular, MD William Beaumont Hospitals
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Responsible Party: Sirisha Nandalur, MD, Radiation Oncologist, Clinical Faculty, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT05568537    
Other Study ID Numbers: 2022-050
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sirisha Nandalur, MD, William Beaumont Hospitals:
MRI
PSMA PET
Pylarify
androgen deprivation therapy
radiation therapy
Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases