18F-rhPSMA-7.3 PET to detect recurrent prostate cancer after focal gland treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PSMA is a protein commonly overexpressed on prostate cancer cells and can be targeted with PET radiotracers to visualize tumor location and extent. This interventional diagnostic protocol uses the 18F‑rhPSMA‑7.3 tracer to image men after focal gland treatment to see if recurrent or residual disease can be detected. Eligible participants are adult men with intermediate‑risk prostate cancer who had focal or hemiablation therapy within the prior 9 months and who have pre‑treatment MRI and biopsy records. Participants will receive the radiotracer, undergo PSMA‑PET imaging, and provide blood samples and follow‑up imaging to compare PET findings with clinical and pathology data.

Why it matters

Who can join: the full rules

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.

Where it's running

• John Theurer Cancer Center at Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Nitin Yerrman, MD — Hackensack Meridian Health
• Study coordinator: Oncology Clinical Research Referral Office
• Email: OncologyResearchReferral@hmhn.org
• Phone: 551-996-1777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.