Prostate MRI and Pylarify PSMA PET/CT

NCT05568537 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2022-050
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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) \[whichever comes first\].

Conditions

Prostate Cancer

Keywords

MRI; PSMA PET; Pylarify; androgen deprivation therapy; radiation therapy; Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

Treatment MRIs and Pylarify PSMA PET/CTs

EXPERIMENTAL

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)

Interventions

Pylarify Piflufolastat Flourine-18 (18F-DCFPyL) DRUG

Piflufolastat F18 will first be given intravenously over about 5 seconds.

Also known as: Pylarify

Treatment MRIs and Pylarify PSMA PET/CTs

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sirisha Nandular, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, Clinical Faculty

Model Details: Non-randomized, prospective, single-institution

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share