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

Not Applicable

Not yet recruiting

• Conditions: Ability of Post-treatment PSMA-PET Scan to Detect Residual Disease
• Interventions: Drug: 18F-rhPSMA-7.3

• Registration Number: NCT07011342
• Lead Sponsor: Hackensack Meridian Health

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study Start: 2025-06-01
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-rhPSMA-7.3	18F-rhPSMA-7.3	Patients will undergo a PSMA-PET scan at 1 year (+/- 60 days) after treatment with SOC focal therapy using a radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)-targeted PET scan using 18F-rhPSMA-7.3 (Posluma). The rhPSMA-targeted PET scan is an FDA-approved PET scan to detect the presence of lesions positive for prostate-specific membrane antigen (PSMA) in men with prostate cancer. 18F-rhPSMA-7.3 (Posluma) injection is a radioactive diagnostic agent that is administered in the form of an intravenous injection.

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy	Approximately 1 year after SOC focal therapy.	All patients will get a biopsy to assess the effectiveness of treatment at 1 year, which is standard protocol at our institutions (all patients undergo biopsy at year 1 and 3 at our institutions). The post-treatment PSMA-PET scan will be correlated to 1-year biopsy results to study the utility of such a scan. Recurrence is defined by a positive PSMA-PET scan and positive biopsy in the area of PET scan tracer uptake at 1 year after SOC focal treatment.

Secondary Outcome Measures

Name	Time	Method
To report the sensitivity and specificity in evaluating PSMA-PET scan	Approximately 1 year after SOC focal therapy.	Sensitivity and specificity will be reported under the ROC and AUC analysis.