Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
Conditions
Prostate CancerDrugs
18F-rhPSMA-7.3Summary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Oncology Clinical Research Referral Office
- 551-996-1777
- [email protected]
Principal Investigator
- Nitin Yerrman, MD
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.
Study Plan
18F-rhPSMA-7.3
EXPERIMENTAL
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).nnThe 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.
DRUG:
18F-rhPSMA-7.3Description:
Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT)
Outcome Measures
Primary Outcome Measures
To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy
Secondary Outcome Measures
To report the sensitivity and specificity in evaluating PSMA-PET scan
Timeline
Last Updated
August 20, 2025Start Date
June 8, 2025Today
December 7, 2025Completion Date ( Estimated )
October 1, 2028
Sponsors of this trial
Lead Sponsor
Hackensack Meridian HealthCollaborating Sponsors
Blue Earth Diagnositcs