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

RECRUITINGN/ASponsored by Hackensack Meridian Health
Actively Recruiting
PhaseN/A
SponsorHackensack Meridian Health
Started2025-10-01
Est. completion2028-11
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions2

CancerProstate Cancer

Locations1 site

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office551-996-1777OncologyResearchReferral@hmhn.org

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