18F-rhPSMA-7.3 PET to detect recurrent prostate cancer after focal gland treatment
Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment
This trial will test whether an 18F-rhPSMA-7.3 PSMA‑PET scan can find recurrent prostate cancer in men who had focal or hemiablation therapy for intermediate‑risk disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT07011342 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult men (≥18 years) with intermediate‑risk prostate cancer who underwent focal or hemiablation therapy within the past 9 months, have a pre‑treatment MRI and standard biopsy, and a life expectancy of at least 10 years.
Not a fit: Men who did not receive focal gland therapy, who fall outside the trial's intermediate‑risk/follow‑up timeframe or lack required pre‑treatment MRI/biopsy, or who cannot travel to the study site are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this imaging approach could help doctors locate recurrent tumors earlier and guide more precise follow‑up or retreatment decisions.
How similar studies have performed: Other PSMA‑PET agents (including 68Ga and 18F tracers) have improved detection of recurrent prostate cancer broadly, but the specific application of 18F‑rhPSMA‑7.3 after focal gland therapy remains relatively novel and less well established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hackensack, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.