Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: piflufolastat (18F); Drug: flotufolastat (18F)

Detailed Description

This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values [SUV]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Los Angeles, California, United States, 90048
      • Tower Urology
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Endeavor Health- Glenbrook Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • XCancer Omaha/Urology Cancer Center
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male ≥18 years of age at Visit 1 (Screening).
• Documented history of localized adenocarcinoma of the prostate with prior curative intent treatment with RP and undetectable PSA post-surgery, experiencing BCR of prostate cancer.
• At least 6 months must have elapsed after RP.
• Low PSA BCR defined as PSA ≤0.5 ng/mL.
• Scheduled by their treating physician to receive a PSMA (18F) PET scan.
• Written informed consent obtained from the patient and ability for the patient to comply with the requirements of the study.

Exclusion Criteria:

• Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
• Patients who are planned to have an x-ray contrast agent or any other PET radiotracer within 24 hours prior to either PSMA PET scan.
• Patients who have already received a piflufolastat (18F) PET scan prior to providing informed consent for this study.
• Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to either of the PSMA PET scans in this study.
• Patients with known hypersensitivity to the active substance or to any of the excipients of piflufolastat (18F) or flotufolastat (18F).
• Patients who have previously undergone a cystectomy or have renal failure, or have other conditions that may significantly affect urinary output, as judged by the investigator.
• Patients who have already received salvage therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET); Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan.	Drug: piflufolastat (18F); Positron emission tomography (PET); Drug: flotufolastat (18F); Positron emission tomography (PET)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET.	Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F). A positive difference represents a lower bladder SUVmean for flotufolastat (18F) compared to piflufolastat (18F).	piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET	Defined as the total number of patients with at least one PET positive lesion / total number of patients.	piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days
Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET	Defined as the total number of patients with at least one PET positive lesion / total number of patients in PSA group.	Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days
Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET		Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days
Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET		Piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days

Collaborators and Investigators

• Sponsor: Blue Earth Diagnostics
• Collaborators: Aixial Group
• Investigators: Principal Investigator: Brian Helfand, M.D., Endeavor Health NorthShore Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BED-PSMA-411

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.: No