Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
- Conditions
- Prostate Cancer
- Interventions
- Drug: rhPSMA-7.3 (18F) InjectionDiagnostic Test: Positron Emission Tomography scan
- Registration Number
- NCT04186819
- Lead Sponsor
- Blue Earth Diagnostics
- Brief 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.
- Detailed Description
Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation \[BIE\]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 356
- Patient is male and aged >18 years old.
- Histologically confirmed adenocarcinoma of the prostate.
- Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
- 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, or with a prior history of, 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 Specificity Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Sensitivity Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
- Secondary Outcome Measures
Name Time Method Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.
Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration TP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading
The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b) Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) PET/CT scans on Day 1 Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)
Trial Locations
- Locations (34)
Tower Urology
🇺🇸Los Angeles, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
MidLantic Urology
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Hospital
🇺🇸Houston, Texas, United States
Richard L Roudebush VA Medical Center
🇺🇸Indianapolis, Indiana, United States
University of California Irvine Medical Center (UCIMC)
🇺🇸Orange, California, United States
Northside Hospital
🇺🇸Austell, Georgia, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Chesapeake Urology Research Associates
🇺🇸Towson, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Urologic Institute of Northeastern New York - Community
🇺🇸Albany, New York, United States
Montefiore Hospital
🇺🇸Bronx, New York, United States
Queens Hospital Center (QHC) - Queens Cancer Center
🇺🇸Jamaica, New York, United States
Mount Sinai Faculty Practice Associates
🇺🇸New York, New York, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Virginia Oncology Associates PC
🇺🇸Norfolk, Virginia, United States
University of Virginia - Health Science Center
🇺🇸Charlottesville, Virginia, United States
Turku University Hospital
🇫🇮Turku, Finland
Klinik und Poliklinik fur Urologie
🇩🇪Hamburg, Germany
CWZ
🇳🇱Nijmegen, Netherlands
TU München
🇩🇪Munich, Germany
Maxima MC
🇳🇱Veldhoven, Netherlands
Urology San Antonio
🇺🇸San Antonio, Texas, United States
University of Michigan, Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States