RecruitingPhase 3NCT07052214

PSMA PET Combined With MRI for the Detection of PCa

A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).


Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

204 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining PSMA PET scan imaging (a specialized nuclear medicine scan that detects prostate cancer cells) with standard MRI improves the detection of clinically significant prostate cancer in men who have not yet had a prostate biopsy. **You may be eligible if:** - You are a male, 18 or older - You have clinical suspicion of prostate cancer (based on elevated PSA, abnormal prostate exam, certain MRI findings, or other risk factors) - You are scheduled for a template prostate biopsy - You have not been previously diagnosed with prostate cancer or received prostate cancer treatment - You are able to lie still for imaging scans **You may NOT be eligible if:** - You have already been treated for prostate cancer or have had a confirmed diagnosis - You have obvious spread of cancer seen on prior imaging - You have had another cancer in the past (except for certain skin cancers) - You have an active urinary tract infection or prostate infection - You have had prior pelvic radiation - You are unable or unwilling to undergo a prostate biopsy - You have a known allergy to the imaging agent used (68Ga-PSMA-11) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-PSMA-11

The radioconjugate 68Ga-PSMA-11 is composed of a human PSMA-targeting ligand peptide conjugated via the acyclic radiometal chelator, N, N'-bis \[2-hydroxy-5-(carboxyethyl)benzyl\] ethylenediamine-N, N'-diacetic acid (HBED-CC) to the radioisotope Gallium68 ( 68Ga); which binds to PSMA on the surface of cells expressing PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. 68Ga is a β+ (beta) ray emitting radionuclide that allows precise imaging via PET.


Locations(1)

Australian Prostate Centre

Melbourne N., Victoria, Australia

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NCT07052214


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