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

Prostate Cancer Clinical Trial

Official title:

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 Newly Diagnosed Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186819
• Other study ID #: BED-PSMA-301
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: March 2022
• Source: Blue Earth Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: February 18, 2022
• Est. primary completion date: June 17, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku
Germany	Klinik und Poliklinik fur Urologie	Hamburg
Germany	TU München	Munich
Netherlands	CWZ	Nijmegen
Netherlands	Maxima MC	Veldhoven
United States	The Urologic Institute of Northeastern New York - Community	Albany	New York
United States	University of Michigan, Ann Arbor	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Northside Hospital	Austell	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Hospital	Bronx	New York
United States	University of Virginia - Health Science Center	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	MD Anderson Hospital	Houston	Texas
United States	Richard L Roudebush VA Medical Center	Indianapolis	Indiana
United States	Queens Hospital Center (QHC) - Queens Cancer Center	Jamaica	New York
United States	Tower Urology	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Mount Sinai Faculty Practice Associates	New York	New York
United States	Virginia Oncology Associates PC	Norfolk	Virginia
United States	University of California Irvine Medical Center (UCIMC)	Orange	California
United States	MidLantic Urology	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Urology San Antonio	San Antonio	Texas
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Stony Brook University	Stony Brook	New York
United States	Chesapeake Urology Research Associates	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Blue Earth Diagnostics	Parexel

Countries where clinical trial is conducted

United States,  Finland,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of rhPSMA-7.3 (18F)	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.	90 days
Primary	Specificity of rhPSMA-7.3 (18F)	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.	90 days
Secondary	Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.	Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.	90 days
Secondary	Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.	Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.	90 days
Secondary	Number of participants with treatment-related adverse events as classified by MedDRA	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.	90 days