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

NCT06604442 | Completed Phase 4 Results FDA Drug

• 1 other identifier: BED-PSMA-411
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient Level Detection Rates Following 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

• Patient Level Detection Rates Stratified by PSA Level Following 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 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

Study Arms (1)

piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)

EXPERIMENTAL

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: flotufolastat (18F); Drug: piflufolastat (18F)

Interventions

flotufolastat (18F) DRUG

Positron emission tomography (PET)

piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)

piflufolastat (18F) DRUG

Positron emission tomography (PET)

piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blue Earth Diagnostics: lead
• Aixial Group: collaborator

Study Sites (9)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Endeavor Health- Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

XCancer Omaha/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Nordquist LT, Andrews JR, Kuo PH, Gartrell BA, Josephson D, Purysko AS, Saltzstein DR, Pathak RA, Shore N, Sykes J, Penny R, Davis P, Helfand BT. An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. Eur J Nucl Med Mol Imaging. 2026 May;53(6):3529-3541. doi: 10.1007/s00259-025-07732-y. Epub 2026 Feb 23.

  PMID: 41729277 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head of Research and Development
• Organization: Blue Earth Diagnostics

matthew.miller@blueearthdx.com

+44 (0) 1865 784 186

Study Officials

• Brian Helfand, M.D.

  Endeavor Health NorthShore Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Positron Emission Tomography (PET) Imaging study

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: December 4, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: July 13, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-06

Locations

US (9)