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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dschust@emory.edu
• Phone: 404-712-4859

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.