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

NCT04186845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2025-09-22

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 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.

Conditions

Interventions

DRUG

rhPSMA-7.3 (18F) Injection

Radioligand for PET CT scanning

DIAGNOSTIC_TEST

Positron emission tomography scan

Imaging scan 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
2020-05-04
Primary Completion
2021-04-28
Completion
2021-04-28
FDA Drug
Yes

Countries

  • United States
  • Finland
  • 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 NCT04186845 on ClinicalTrials.gov