An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique

Launched by EMORY UNIVERSITY · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 18F-rhPSMA-7.3 PET-multiparametric MRI (mpMRI) to help identify prostate cancer in men who are suspected of having the disease. The goal is to see if this new imaging method can better show where tumors are located in the prostate, compared to the standard mpMRI alone. By doing this, the researchers hope to improve the accuracy of a specific type of biopsy called transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy, which is used to remove tissue samples for testing.

To be eligible for this study, participants must be male, at least 18 years old, and have suspected prostate cancer that requires a biopsy for confirmation. They should also be able to stay still during the MRI scan and provide written consent to participate. However, individuals with certain health issues, such as severe urinary problems or specific medical implants, may not be able to join. Participants can expect to undergo imaging tests and a biopsy, and they will be closely monitored throughout the study to help determine if this new imaging technique is effective in identifying prostate tumors.

Gender

MALE

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