Clinical Trials /

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)

NCT04186819

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04186819

Trial Eligibility

Document

Title

  • Brief Title: Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: BED-PSMA-301
  • NCT ID: NCT04186819

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
rhPSMA-7.3 (18F) InjectionPatients

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PatientsExperimentalSingle intravenous administration of rhPSMA-7.3 (18F) for PET Scan
  • rhPSMA-7.3 (18F) Injection

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).
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Sensitivity of rhPSMA-7.3 (18F)
Time Frame:90 days
Safety Issue:
Description:Sensitivity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level. At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level.

Secondary Outcome Measures

Measure:Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.
Time Frame:90 days
Safety Issue:
Description:Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
Measure:Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.
Time Frame:90 days
Safety Issue:
Description:Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
Measure:Number of participants with treatment-related adverse events as classified by MedDRA
Time Frame:90 days
Safety Issue:
Description: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.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Blue Earth Diagnostics

Trial Keywords

  • Primary Prostate Cancer
  • Diagnostic
  • Prostate Specific Membrane Antigen (PSMA)
  • Positron Emission Tomography (PET) Scan

Last Updated

March 9, 2021