CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 391 enrolled
Drug / intervention
rhPSMA-7.3 (18F) Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04186845
NCT04186845Phase 3Completed

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)

Blue Earth Diagnostics·interventional·Posted Dec 5, 2019·Updated Sep 22, 2025

In Brief

A Phase 3 clinical trial evaluating rhPSMA-7.3 (18F) Injection and Positron emission tomography scan for Prostate Cancer. Completed, enrolled 391 participants across 28 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesFinland, Netherlands, United States
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 5, 2019
Enrollment StartMay 4, 2020
Primary CompletionApr 28, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.6 years ago

Interventions

rhPSMA-7.3 (18F) Injectiondrug

Radioligand for PET CT scanning

Positron emission tomography scanother

Imaging scan with radioligand