Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

NCT04186845 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BED-PSMA-302
• Study Type: interventional
• Target: 391
• Locations: 3 countries
• Sites: 28

Brief Summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Conditions

Prostate Cancer

Keywords

Recurrent Prostate Cancer; Diagnostic; Prostate Specific Membrane Antigen (PSMA); Positron Emission Tomography (PET) Scan

Outcome Measures

Primary Outcomes (1)

• Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT

  The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.

  Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

Secondary Outcomes (8)

• Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging

  Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

• Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available

  Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

• Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level

  Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

• CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other

  Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

• Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)

  Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

Study Arms (1)

Patients

EXPERIMENTAL

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Drug: rhPSMA-7.3 (18F) Injection; Diagnostic Test: Positron emission tomography scan

Interventions

rhPSMA-7.3 (18F) Injection DRUG

Radioligand for PET CT scanning

Also known as: flotufolastat F18

Patients

Positron emission tomography scan DIAGNOSTIC_TEST

Imaging scan with radioligand

Also known as: PET scan

Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients required to have suspected prostate cancer recurrence based on elevated PSA following prior therapy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male and aged \>18 years old.
• History of localized adenocarcinoma of the prostate with prior curative intent treatment.
• An elevated PSA, clinically suspicious for biochemically recurrent disease:
• Following Radical Prostatectomy: PSA \>0.2 ng/mL
• Following Radiotherapy: nadir +2 ng/mL.
• Potentially eligible for salvage therapy with curative intent.

You may not qualify if:

• Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
• Patients currently receiving Androgen Deprivation Therapy (ADT).

Sponsors & Collaborators

• Blue Earth Diagnostics: lead
• Parexel: collaborator

Study Sites (28)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

University of California Irvine Medical Center (UCIMC)

Orange, California, 92868, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90403, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Austell, Georgia, 30342, United States

Location

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

University of Michigan Ann Arbor

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Queens Hospital Center (QHC - Queens Cancer Center

Jamaica, New York, 11432, United States

Location

Mount Sinai Faculty Practice Associates

New York, New York, 10029, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Montefiore Hospital

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MidLantic Urology

Philadelphia, Pennsylvania, 19004, United States

Location

MD Anderson Hospital

Houston, Texas, 77054, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia - Health Science Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Turku University Hospital

Turku, FI-20520, Finland

Location

CWZ

Nijmegen, 6532, Netherlands

Location

Maxima MC

Veldhoven, 5504 DB, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Injections; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Head of R&D
• Organization: Blue Earth Diagnostics

matthew.miller@blueearthdx.com

+44 (0) 1865 784 186

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: November 22, 2019
• First Posted: December 5, 2019
• Study Start: May 4, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: September 22, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-09

Locations

NL (2); US (25); FI (1)