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NCT07011342NARecruiting

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

Hackensack Meridian Health

Start Date

10/1/2025

Completion Date

11/1/2028

Summary

To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy

Detailed Description

PSMA is a protein that is highly expressed in prostate cancer cells, making it an excellent specific target for imaging with PET scans that can provide detailed information about the location, extent and aggressiveness of prostate cancer lesions. These scans have proven invaluable for identifying and characterizing prostate cancer, aiding in treatment planning, and Monitoring treatment response. It's true and fully utility in focal therapy for prostate cancer is unknown.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

18F-rhPSMA-7.3

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Conditions

Prostate Cancer

Locations

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States