NCT06865768 An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique
| NCT ID | NCT06865768 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Emory University |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-04-18 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.
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
Contact & Investigator
David M Schuster, MD, FACR
PRINCIPAL INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Frequently Asked Questions
Who can join the NCT06865768 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06865768 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06865768 currently recruiting?
Yes, NCT06865768 is actively recruiting participants. Contact the research team at dschust@emory.edu for enrollment information.
Where is the NCT06865768 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT06865768 clinical trial?
NCT06865768 is sponsored by Emory University. The principal investigator is David M Schuster, MD, FACR at Emory University Hospital/Winship Cancer Institute. The trial plans to enroll 90 participants.