Clinical trial NCT04186819: Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
Official title: 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 Newly Diagnosed Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Primary Prostate Cancer
Diagnostic
Prostate Specific Membrane Antigen (PSMA)
Positron Emission Tomography (PET) Scan
Lead sponsor: Blue Earth Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2019-12-05
Enrollment: 356
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Positron Emission Tomography (PET) Imaging study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Patient is male and aged \>18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

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, or with a prior history of, Androgen Deprivation Therapy (ADT).

Primary outcomes:
measure: Specificity
timeFrame: 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
measure: Sensitivity
timeFrame: 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
Secondary outcomes:
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
timeFrame: 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
measure: The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)
timeFrame: 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
measure: Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
timeFrame: PET/CT scans on Day 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center (UCIMC)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Austell
country: United States
facility: Northside Hospital
state: Georgia
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Richard L Roudebush VA Medical Center
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Ann Arbor
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: The Urologic Institute of Northeastern New York - Community
state: New York
city: Bronx
country: United States
facility: Montefiore Hospital
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center (QHC) - Queens Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai Faculty Practice Associates
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Hospital
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia - Health Science Center
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates PC
state: Virginia
city: Turku
country: Finland
facility: Turku University Hospital
city: Hamburg
country: Germany
facility: Klinik und Poliklinik fur Urologie
city: Munich
country: Germany
facility: TU München
city: Nijmegen
country: Netherlands
facility: CWZ
city: Veldhoven
country: Netherlands
facility: Maxima MC
Study officials:
References: