Can a new scan unmask hidden prostate cancer and guide precise treatment?

NCT ID NCT07788625

Disease control Sponsor: The University of Hong Kong Source: ClinicalTrials.gov ↗

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether a special PET-CT scan can spot aggressive prostate cancers that standard MRI fails to see. Men aged 50 and older with intermediate-risk prostate cancer and at least one MRI-invisible tumor will receive the scan; if it lights up the hidden cancer, they will undergo targeted focal therapy using heat, ultrasound, or electrical pulses to destroy only the tumor. The goal is to see if this approach can eliminate the cancer in the treated area while sparing healthy tissue, potentially offering a middle ground between whole-gland treatment and active surveillance.

What this could mean

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

Active substance: Focal therapy (targeted microwave ablation, high-intensity focused ultrasound, or irreversible electroporation) guided by ¹⁸F-PSMA-1007 PET-CT
What this could lead to: If successful, this could enable men with MRI-invisible prostate cancer to receive precise, targeted treatment instead of whole-gland surgery or radiation, potentially reducing side effects while controlling the disease.
What could go wrong: This is a phase II trial with a modest number of participants, so results may not generalize. The approach depends on PET-CT accurately spotting lesions that MRI misses, and there is a risk of missing cancer or damaging nearby tissue during ablation.

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Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

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

50 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. Men aged ≥50 years 2. Life expectancy \>10 years 3. Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3 4. At least one clinically significant cancer focus (≥1 systematic biopsy core with Grade Group 2-3) that is MRI-invisible, defined as: \- The corresponding sextant/region on mpMRI (performed within 6 months) shows PI-RADS v2.1 score 1 or 2, or no identifiable lesion that could account for the positive biopsy 5. Total of 1-2 discrete cancer foci (MRI-visible + PET-detected MRI-invisible) on study entry, with each MRI-visible focus having maximum diameter ≤15 mm on mpMRI 6. Organ-confined disease on mpMRI and no evidence of seminal vesicle invasion or lymph node/distant metastasis 7. Serum PSA \<20 ng/mL 8. Able to provide informed consent Exclusion Criteria: 1. Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation) 2. Prior pelvic radiotherapy for any cause 3. Contraindication to MRI or gadolinium contrast 4. Contraindication to PSMA PET-CT (e.g. severe claustrophobia, inability to lie flat) 5. Contraindication to general or spinal anaesthesia 6. Uncorrectable coagulopathy (INR \>1.5, platelet \<50×10⁹/L) or anticoagulant/antiplatelet therapy that cannot be stopped (low-dose aspirin 80-100 mg is permitted) 7. Active urinary tract infection or acute prostatitis 8. MRI-invisible focus located in a region where focal therapy would likely cause sphincter or rectal injury, as determined by biopsy mapping and anatomical constraints 9. Bladder pathology (bladder stone, bladder cancer) or known urethral stricture

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a new scan unmask hidden prostate cancer and guide precise treatment?

What the study statuses mean