PSMA PET and MRI for Prostate Cancer Detection

This study is looking at how well a special type of scan, called PSMA PET, combined with an MRI (magnetic resonance imaging) can find prostate cancer. The PSMA PET scan uses a small amount of a drug called 68Ga-PSMA-11, which helps highlight prostate cancer cells. Researchers want to see if this combination is better than the usual ways doctors find prostate cancer. You might be able to join if you are a man at least 18 years old and your doctor suspects you might have prostate cancer, especially if you've had an MRI showing some concerns or have other risk factors like a high PSA (prostate-specific antigen) level. The study aims to enroll 338 participants. The main goals of the study will be measured after 12 months.

Study design
This is an open-label, single-arm study, meaning you and your doctors will know what treatments you are receiving. It plans to enroll 338 participants across multiple locations.
What's involved
You would undergo MRI and PSMA PET scans, followed by a standard prostate biopsy. If your doctor decides not to perform a biopsy, you will have a follow-up visit at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured at 12 months. If a biopsy is not performed, you will have a follow-up visit at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07052214

PSMA PET Combined With MRI for the Detection of PCa

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Telix Pharmaceuticals (Innovations) Pty Limited
~338 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:68Ga-PSMA-11

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Objective
Measured over 12 months
+1 more outcome measured
PCA
Prostate Cancer
Prostatic Neoplasm
PSMA PET
Diagnostic Imaging
Elevated PSA
Positron Emission Tomography
Prostate Biopsy
Carcinoma of the Prostate
18 sites across 14 states
California2
Florida2
Louisiana2
Tennessee2
Illinois1
Indiana1
Missouri1
New York1

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  • Primary Objective12 months

    To evaluate the diagnostic performance of combined 68Ga-PSMA-11 PET and MRI targeted biopsy for the detection of PCa, using histopathological confirmation as the SOT.

  • Co-Primary Endpoint12 months

    To assess the sensitivity and specificity of 68Ga-PSMA-11 PET as adjunct to MRI or the detection of PCa, confirmed by predefined standard of truth (SOT).