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

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: rhPSMA-7.3 (18F) Injection
Diagnostic Test: Positron emission tomography scan

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: The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 391

Inclusion Criteria

Patient is male and aged >18 years old.
History of localized adenocarcinoma of the prostate with prior curative intent treatment.
An elevated PSA, clinically suspicious for biochemically recurrent disease:
- Following Radical Prostatectomy: PSA >0.2 ng/mL
- Following Radiotherapy: nadir +2 ng/mL.
Potentially eligible for salvage therapy with curative intent.

Exclusion Criteria

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

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
Patients	Positron emission tomography scan	Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Primary Outcome Measures

Name	Time	Method
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.

Secondary Outcome Measures

Name	Time	Method
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The analysis was performed for each region and for each of the blinded independent readers
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers	PET Scan on Day 1	The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify patients.
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available	Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan	Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard.

Trial Locations

Locations (28): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Tower Urology
🇺🇸
Los Angeles, California, United States
University of California Irvine Medical Center (UCIMC)
🇺🇸
Orange, California, United States
John Wayne Cancer Institute
🇺🇸
Santa Monica, California, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Northside Hospital
🇺🇸
Austell, Georgia, United States
Northshore University HealthSystem
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Evanston, Illinois, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
Chesapeake Urology Research Associates
🇺🇸
Towson, Maryland, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States