NCT04186819

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Blue Earth Diagnostics · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	rhPSMA-7.3 (18F) Injection	Radioligand for PET CT scanning
DIAGNOSTIC_TEST	Positron Emission Tomography scan	imaging test with radioligand

Timeline

• Start date: 2020-03-02
• Primary completion: 2021-06-21
• Completion: 2021-06-21
• First posted: 2019-12-05
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

34 sites across 4 countries: United States, Finland, Germany, Netherlands

Regulatory

• FDA-regulated drug study