Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.

NCT04186819 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BED-PSMA-301
• Study Type: interventional
• Target: 356
• Locations: 4 countries
• Sites: 34

Brief Summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Specificity

  The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

• Sensitivity

  The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

Secondary Outcomes (8)

• Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration

• Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

• Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

• PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

• NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)

  Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

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: No other interventions

Patients

Positron Emission Tomography scan DIAGNOSTIC_TEST

imaging test with radioligand

Also known as: PET scan

Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients required to have unfavorable intermediate-, high-risk or very high-risk Prostate Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male and aged \>18 years old.
• Histologically confirmed adenocarcinoma of the prostate.
• Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

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, or with a prior history of, Androgen Deprivation Therapy (ADT).

Sponsors & Collaborators

• Blue Earth Diagnostics: lead
• Parexel: collaborator

Study Sites (34)

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

Richard L Roudebush VA Medical Center

Indianapolis, Indiana, 46278, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, 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

The Urologic Institute of Northeastern New York - Community

Albany, New York, 12208, 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

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, 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 PC

Norfolk, Virginia, 23502, United States

Location

Turku University Hospital

Turku, FI-20520, Finland

Location

Klinik und Poliklinik fur Urologie

Hamburg, 20246, Germany

Location

TU München

Munich, 81675, Germany

Location

CWZ

Nijmegen, 6532, Netherlands

Location

Maxima MC

Veldhoven, 5504 DB, Netherlands

Location

Related Publications (1)

• Surasi DS, Eiber M, Maurer T, Preston MA, Helfand BT, Josephson D, Tewari AK, Somford DM, Rais-Bahrami S, Koontz BF, Bostrom PJ, Chau A, Davis P, Schuster DM, Chapin BF; LIGHTHOUSE Study Group. Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). Eur Urol. 2023 Oct;84(4):361-370. doi: 10.1016/j.eururo.2023.06.018. Epub 2023 Jul 5.

  PMID: 37414702 DERIVED

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: March 2, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (29); NL (2); FI (1); DE (2)