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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04186819
Other study ID # BED-PSMA-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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