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

Blue Earth Diagnostics391 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

391

Conditions

Prostate Cancer

Interventions

rhPSMA-7.3 (18F) InjectionDRUG

Radioligand for PET CT scanning

Positron emission tomography scanDIAGNOSTIC_TEST

Imaging scan with radioligand

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (28)

Outcomes

Primary Outcomes

Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT

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.

Time frame: 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

Secondary Outcomes

Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging

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.

Time frame: 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 and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available

Time frame: 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 of rhPSMA-7.3 (18F) PET Stratified by PSA Level

Data from ClinicalTrials.gov

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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

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

...and 18 more locations

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

Time frame: 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

CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other

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

Time frame: 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

Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)

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

Time frame: 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

Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers

The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers

Time frame: PET Scan on Day 1

Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level

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.

Time frame: 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 of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available

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.

Time frame: 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