NCT04186845

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

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 (SPOTLIGHT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 391 (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 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.

Detailed description

The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).

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 scan with radioligand

Timeline

• Start date: 2020-05-04
• Primary completion: 2021-04-28
• Completion: 2021-04-28
• First posted: 2019-12-05
• Last updated: 2025-09-22
• Results posted: 2025-02-26

Locations

28 sites across 3 countries: United States, Finland, Netherlands

Regulatory

• FDA-regulated drug study