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

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) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186845
• Other study ID #: BED-PSMA-302
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2020
• Est. completion date: October 12, 2021

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: October 12, 2021
• Est. primary completion date: April 9, 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. 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.

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku
Netherlands	CWZ	Nijmegen
Netherlands	Maxima MC	Veldhoven
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	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
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	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	Norfolk	Virginia
United States	University of California Irvine Medical Center (UCIMC)	Orange	California
United States	MidLantic Urology	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,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	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