NCT07052214

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).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a single arm, multicenter, prospective, open label Phase 3 study with PSMA PET for the detection of PCa. A total of 204 participants will be enrolled from approximately 25 investigative sites in the United States and Australia. Participants with a clinical suspicion of PCa, who will undergo template biopsy, based on initial MRI (PI-RADs 3-4) within 3 months (92 days) before enrollment and/or based on clinical suspicion (for PI-RADs 1-2) and who have never undergone a prostate biopsy will be eligible for the study. All participants will first undergo MRI and PSMA PET scans, followed by standard 12 core anatomical (2 core six sectors) template biopsy. If the patient does not have a biopsy, their enrollment in the study will be terminated. If additional lesions are detected on MRI and/or PSMA PET, MRI and/or PMSA PET targeted biopsy can be performed (according to clinician judgment). Both MRI and/or PSMA targeted biopsies will be performed with 2 cores per lesion or as per institutional standards. Clinicians may use PSMA PET to rule out the need for biopsy, in which case, the patient will not have a histopathological SOT and will terminate their enrollment. All biopsy and clinical care decisions are at the discretion of the investigator/clinician (i.e. the clinician may decide to: not biopsy, solely template biopsy, additional targeted biopsies, etc.) Participants presenting with csPCa will undergo therapy/management as per institutional standard, or according to clinician judgment. Follow-up data will be collected for up to 6-months for select participants (participants with no baseline imaging or histopathological evidence of PCa). Additional imaging, template and/or targeted biopsies may be performed during the follow-up period, at the discretion of the investigator. Any additional biopsy, imaging, clinical, histological, genetic, and intervention data will contribute to the determination of the CSOT. Follow-up will provide longitudinal surveillance to ensure that participants initially evaluated as negative for PCa on both imaging and histopathology are reliably negative.

Conditions

• PCA
• Prostate Cancer
• Prostatic Neoplasm
• PSMA PET
• Diagnostic Imaging
• Elevated PSA
• Positron Emission Tomography
• Prostate Biopsy
• Carcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	68Ga-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.

Timeline

• Start date: 2025-08-18
• Primary completion: 2026-06-01
• Completion: 2026-11-01
• First posted: 2025-07-04
• Last updated: 2025-09-10

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study