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Updated: Mar 17, 2026
A New Technique for Treating Low-risk Prostate Cancer—Super Active Surveillance
Published on: November 7, 2025
A Pilot Study of 18F-rhPSMA-7.3-PET/MRI to Reduce Mischaracterization of Active Surveillance and Focal Therapy
Ridwan Alam1, Derek Hesse2, Nikki Hubbard1
1Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Introduction:
PSMA-PET offers an opportunity to reduce the mischaracterization of disease in active surveillance (AS) and focal therapy (FT) candidates. We describe the results of a pilot clinical trial evaluating 18F-radiohybrid(rh)PSMA-7.3-PET/MRI to detect occult adverse pathology among potential AS and FT candidates (NCT05852041).
Methods:
We enrolled 20 men with low risk or favorable intermediate risk prostate cancer and Decipher score ≥ 0.45 diagnosed after an MRI-informed prostate biopsy. All patients underwent PSMA-PET/MRI followed by either PET/MRI-guided biopsy or radical prostatectomy within 90 days. The outcome of interest was detection of grade group (GG) 3-5 disease, seminal vesicle invasion (pT3b), or lymph node involvement (pN1). A detection rate of 15% for this outcome was considered clinically significant. Management decisions and confidence in those decisions were recorded before and after the scan using a 3-point scale. A paired t-test was performed to compare the change in confidence decisions.
Results:
At enrollment, 17 patients (85%) had favorable intermediate risk and 3 (15%) had low risk prostate cancer. The median Decipher score was 0.58 (IQR 0.49-0.65). Five patients (25%) demonstrated the outcome of interest based on upgrading alone. None had upstaging to pT3b or pN1. Major changes in management plan occurred in 7 patients (35%). Average confidence in decisions improved from moderate (2.05) to high (2.80) after the scan (p < 0.001).
Conclusions:
18F-rhPSMA-7.3-PET/MRI can detect occult higher risk disease in men who are otherwise candidates for AS or FT. The scan prompted major changes in management and increased confidence in the final treatment strategy.
Insights
18F-rhPSMA-7.3-PET/MRI effectively detects hidden high-risk prostate cancer in active surveillance and focal therapy candidates. This imaging improves management decisions and boosts clinician confidence in treatment strategies.
Area of Science:
- Oncology
- Radiology
- Nuclear Medicine
Background:
- Prostate cancer management requires accurate staging to avoid mischaracterization.
- Active surveillance (AS) and focal therapy (FT) candidates may benefit from advanced imaging to detect occult adverse pathology.
- 18F-radiohybrid(rh)PSMA-7.3-PET/MRI is being evaluated for its diagnostic utility in this patient population.
Purpose of the Study:
- To evaluate the efficacy of 18F-rhPSMA-7.3-PET/MRI in identifying occult higher-risk disease among potential AS and FT candidates.
- To assess the impact of 18F-rhPSMA-7.3-PET/MRI on management decisions and clinician confidence.
Main Methods:
- A pilot clinical trial enrolled 20 men with low or favorable intermediate-risk prostate cancer and a high Decipher score (≥0.45).
- All participants underwent 18F-rhPSMA-7.3-PET/MRI followed by biopsy or radical prostatectomy.
- The study assessed the detection of grade group 3-5 disease, seminal vesicle invasion, or lymph node involvement, alongside changes in management plans and decision confidence.
Main Results:
- Five patients (25%) were found to have higher-risk disease (upgrading alone).
- No patients were upstaged to seminal vesicle invasion (pT3b) or lymph node involvement (pN1).
- Major changes in management occurred in 35% of patients, and confidence in treatment decisions significantly improved post-scan (p < 0.001).
Conclusions:
- 18F-rhPSMA-7.3-PET/MRI is effective in detecting occult higher-risk prostate cancer in candidates for AS or FT.
- The imaging modality led to significant changes in patient management and increased clinician confidence.
- This technology holds promise for refining treatment strategies in select prostate cancer patients.
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