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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: rhPSMA-7.3 (18F) Injection

• Registration Number: NCT04186819
• Lead Sponsor: Blue Earth Diagnostics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Study Start: 2020-02-12
• Primary Completion: 2021-06-17
• Study Completion: 2022-02-18
• Status Verified: 2022-03
• Disposition First Submitted: 2022-03-15
• Disposition First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Disposition First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 356

Inclusion Criteria

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

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Exclusion Criteria

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
2. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	rhPSMA-7.3 (18F) Injection	Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Primary Outcome Measures

Name	Time	Method
Specificity of rhPSMA-7.3 (18F)	90 days	Specificity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level.; At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level.
Sensitivity of rhPSMA-7.3 (18F)	90 days	Sensitivity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level.; At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level.

Secondary Outcome Measures

Name	Time	Method
Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.	90 days	Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
Number of participants with treatment-related adverse events as classified by MedDRA	90 days	Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period.
Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.	90 days	Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.

Trial Locations

Locations (34)

Tower Urology; 🇺🇸 Los Angeles, California, United States

John Wayne Cancer Institute; 🇺🇸 Santa Monica, California, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

MidLantic Urology; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Hospital; 🇺🇸 Houston, Texas, United States

Richard L Roudebush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States

University of California Irvine Medical Center (UCIMC); 🇺🇸 Orange, California, United States

Northside Hospital; 🇺🇸 Austell, Georgia, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Chesapeake Urology Research Associates; 🇺🇸 Towson, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

The Urologic Institute of Northeastern New York - Community; 🇺🇸 Albany, New York, United States

Montefiore Hospital; 🇺🇸 Bronx, New York, United States

Queens Hospital Center (QHC) - Queens Cancer Center; 🇺🇸 Jamaica, New York, United States

Mount Sinai Faculty Practice Associates; 🇺🇸 New York, New York, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Virginia Oncology Associates PC; 🇺🇸 Norfolk, Virginia, United States

University of Virginia - Health Science Center; 🇺🇸 Charlottesville, Virginia, United States

Turku University Hospital; 🇫🇮 Turku, Finland

Klinik und Poliklinik fur Urologie; 🇩🇪 Hamburg, Germany

CWZ; 🇳🇱 Nijmegen, Netherlands

TU München; 🇩🇪 Munich, Germany

Maxima MC; 🇳🇱 Veldhoven, Netherlands

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Michigan, Ann Arbor; 🇺🇸 Ann Arbor, Michigan, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States