Clinical Trials /

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

NCT04186845

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)
  • Official Title: A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.

Clinical Trial IDs

  • ORG STUDY ID: BED-PSMA-302
  • NCT ID: NCT04186845

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 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.

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

Primary Outcome Measures

Measure:Positive Predictive Value (PPV) of rhPSMA-7.3 (18F) PET on a patient level using histopathology or confirmatory imaging as a Standard of Truth (SoT).
Time Frame:90 days
Safety Issue:
Description:PPV (defined as true positive [TP]/{TP+false positive [FP]}) of rhPSMA-7.3 (18F) PET using histopathology or confirmatory imaging as a Standard of Truth (SoT).

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

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

Last Updated

April 29, 2021