New scan spots prostate cancers standard MRI misses

NCT ID NCT04461509

Diagnosis Sponsor: Alessandro D'Agnolo Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tested whether a high-resolution PET-MRI scan using a prostate-specific tracer (18F-PSMA) can find cancers that standard MRI might miss. 62 men with prostate cancer considering focal therapy or surgery received both scans, and results were checked with biopsies. The goal was to see if the advanced imaging improves cancer mapping before treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: 18F-PSMA (18F-DCFPyL injection, a radioactive tracer for PET imaging)
What this could lead to: If successful, this imaging approach could help doctors map prostate cancer more accurately, potentially reducing the chance of missing aggressive tumors before treatment.
What could go wrong: This is a small Phase 2 study (62 participants) focused on imaging accuracy, not treatment outcomes. The results may not apply to all prostate cancer patients or change standard care yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

62 people

The number who actually took part.

Started

Apr 2021

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Biopsy consisting of ≥ 10 tissue cores sampled 2. PSA \<20 ng/mL (for HIFU arm only) 3. cT1-cT2c 4. Either overall Gleason score \> 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core (for HIFU arm only) 5. Patient considering focal HIFU therapy or robotic radical prostatectomy Exclusion Criteria: 1. Previous local therapy for prostate cancer 2. Inability to receive PET tracer 3. Inability to receive MRI 4. Estimated glomerular filtration rate (GFR) \<15 mL/min/1.73 m2 5. Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

male reproductive organ cancer male reproductive system disorder neoplasm Neoplasms by Site prostate cancer prostate disorder prostate neoplasm reproductive system disorder Urogenital Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genital diseases, male Genital neoplasms, male Neoplasms Neoplasms by site Prostatic disease Prostatic neoplasms Urogenital neoplasms

New scan spots prostate cancers standard MRI misses

What the study statuses mean