18F-rhPSMA-7.3 PET-mpMRI to guide targeted prostate biopsy with TRUS‑MR fusion

Prospective Phase II Validation of the Performance of a Prostate-Specific Membrane Antigen (PSMA) Radiotracer for Positron Emission Tomography-Multiparametric Magnetic Resonance (PET-mpMR) Imaging to Target Prostate Biopsy Via Transrectal Ultrasound (TRUS) -Magnetic Resonance Imaging (MRI) Fusion Technique

This phase II trial tests whether adding an 18F-rhPSMA-7.3 PET scan to standard mpMRI helps find clinically significant prostate cancer in men scheduled for prostate biopsy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Emory University (other)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT06865768 on ClinicalTrials.gov

What this trial studies

This phase II trial gives an intravenous injection of the PET tracer 18F-rhPSMA-7.3, waits about 50 minutes, and performs PET imaging concurrently with standard-of-care multiparametric MRI to produce combined PET-mpMRI images. Radiologists will identify PI-RADS ≥3 lesions and use TRUS-MR fusion to guide targeted transrectal ultrasound biopsies of those areas. The primary aim is to see if PET-mpMRI improves detection of clinically significant prostate cancer in MRI-suspicious lesions, and secondary analyses will explore radiomics textural features from PET and MRI that correlate with cancer presence. The trial enrolls adult men suspected of having prostate cancer and is conducted at Emory University Hospital.

Who should consider this trial

Good fit: Men over 18 who are suspected of having prostate cancer, are scheduled for prostate biopsy, can lie still for MRI, and can provide informed consent are eligible.

Not a fit: Patients with recent prostatitis, recent prostate biopsy within four weeks, MRI contraindications (for example pacemakers or cochlear implants), hip prostheses, or other conditions that prevent safe MRI or biopsy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve detection of clinically significant prostate cancer and make targeted biopsies more accurate, potentially reducing missed cancers and unnecessary sampling.

How similar studies have performed: PSMA PET combined with MRI has shown promise in improving prostate cancer detection in other studies, but the specific use of 18F-rhPSMA-7.3 with simultaneous PET-mpMRI and radiomics is relatively new and still being tested.

Eligibility criteria

Inclusion Criteria:

* Male subjects aged \> 18 years
* Patients with suspected prostate cancer who will have prostate biopsy for confirmation
* Ability to lie still for MRI scanning
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections
* Patients with contraindications for MRI including implantable pace makers, cochlear implants
* Patients with uni- or bilateral hip prosthesis
* Subjects with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments
* Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect PET-mpMR result
* Is determined by the Investigator that the patient is clinically unsuitable for the study
* Is incapable of understanding the language in which the information for the patient is given
* Participation in a concurrent clinical trial or in another trial within the past 30 days

Where this trial is running

Atlanta, Georgia

• Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: David M Schuster, MD, FACR — Emory University Hospital/Winship Cancer Institute
• Study coordinator: David M. Schuster, MD, FACR

Conditions: Prostate Carcinoma