Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment

Launched by HACKENSACK MERIDIAN HEALTH · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of scan called a PSMA-PET scan to see how well it can detect prostate cancer that may still be present after a treatment called focal therapy. Focal therapy is a way to target and treat specific areas of the prostate that have cancer while trying to leave other parts of the gland unharmed. The goal is to find out if this scan can identify any remaining cancer in men who have had this treatment within the last nine months.

To participate in the trial, men must be 18 years or older and have had a specific type of focal therapy for prostate cancer, which is considered to be of intermediate risk. They need to have had an MRI before their treatment and must be able to understand the purpose of the trial and agree to follow its guidelines. Participants will undergo the PSMA-PET scan and may need to provide some blood samples during the study. It's important to note that the trial is not yet recruiting participants, so there will be no immediate opportunities to join it at this time.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Adult males 18 years or older;
• • Patient must have a pre-treatment MRI;
• • Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment;
• • Intermediate risk disease as defined by American Urology Academy (AUA)/National Comprehensive Cancer Network (NCCN) guidelines (see Appendix A)
• • Life Expectancy of 10 years or more;
• • Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present;
• • Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and
• • Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.
• Exclusion Criteria:
• • Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only.
• • Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.