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

NCT04186819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2025-02-26

Study results available
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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.

Conditions

Interventions

DRUG

rhPSMA-7.3 (18F) Injection

Radioligand for PET CT scanning

DIAGNOSTIC_TEST

Positron Emission Tomography scan

imaging test with radioligand

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Blue Earth Diagnostics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-06-21
Completion
2021-06-21
FDA Drug
Yes

Countries

  • United States
  • Finland
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04186819 on ClinicalTrials.gov