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

Phase 3

Completed

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

• Registration Number: NCT04186845
• Lead Sponsor: Blue Earth Diagnostics

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.

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: 2020-05-05
• Primary Completion: 2021-04-09
• Study Completion: 2021-10-12
• 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: 391

Inclusion Criteria

1. Patient is male and aged >18 years old.

2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.

3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

   • Following Radical Prostatectomy: PSA >0.2 ng/mL
   • Following Radiotherapy: nadir +2 ng/mL.

4. Potentially eligible for salvage therapy with curative intent.

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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 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
Positive Predictive Value (PPV) of rhPSMA-7.3 (18F) PET on a patient level using histopathology or confirmatory imaging as a Standard of Truth (SoT).	90 days	PPV (defined as true positive \[TP\]/{TP+false positive \[FP\]}) of rhPSMA-7.3 (18F) PET using histopathology or confirmatory imaging as a Standard of Truth (SoT).

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.
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.
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.

Trial Locations

Locations (28)

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

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

Maxima MC; 🇳🇱 Veldhoven, Netherlands

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

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

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

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

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

Turku University Hospital; 🇫🇮 Turku, Finland

CWZ; 🇳🇱 Nijmegen, Netherlands

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

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

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

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

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

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

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

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

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

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

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

MidLantic Urology; 🇺🇸 Philadelphia, Pennsylvania, United States

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

Northside Hospital; 🇺🇸 Austell, Georgia, United States

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

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

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

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