Could a quick radiation shot keep prostate cancer in check without surgery?

NCT ID NCT07152067

Disease control Sponsor: Centre Hospitalier Universitaire de Liege Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares a precise, focused radiation treatment (stereotactic body radiotherapy) to simply watching the cancer (active surveillance) in men with low-to-intermediate risk prostate cancer. The goal is to see if the radiation can reduce the number of men who later need stronger treatments like surgery or full radiation. About 146 men will take part, and the study is not yet recruiting.

What this could mean

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

Active substance: Stereotactic body radiation therapy (SBRT)
What this could lead to: If successful, this approach could offer a non-invasive way to lower the chance of needing more aggressive treatments later, while avoiding the anxiety of just watching the cancer.
What could go wrong: This is a Phase 2 trial with only 146 participants, so results are preliminary. The treatment may not reduce rescue treatment rates as hoped, and there are risks of side effects from radiation.

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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

About 146 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2033

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 (all the criteria must be fulfilled ) : * a. Localized prostate adenocarcinoma CAPRA score ≤ 5. This lesion is considered the Index lesion * b. Macroscopic tumor PIRADS score \>4 on multiparametric MRI * c. The biopsies must be pathologic in or in the direct vicinity (the same prostatic zone defined as a quarter volume of the prostate (PZ)) of the MRI pathologic nodule * d. The absence of MRI pathologic criteria (PIRADS ≤3) in a Gleason score ≤ 6 (3+3)-ISUP Grade1 zone outside of the single Index lesion is considered clinically non-significant and does not preclude inclusion * e. The lesion can be plurifocal in a same intent to treat PZ * f. WHO Performance Status 0-1 * g. No major urinary symptoms with IPSS score ≤15 and urinary continence ICIQ score =0 * h. Patient is candidate for AS * Exclusion Criteria : * a. Age at diagnosis \< 50 years * b. Time between initial diagnostic biopsies and randomization \> 4 months, or radiation therapy initiation \> 6 months * c. Cribriform or Intraductal histologic components * d. Gleason Score ≥7 (3+4)-ISUP Grade 2 biopsy outside the intent to treat PZ * e. Multicentric pathologic MRI (PIRADS ≥4) outside a same PZ * f. Initial PSA \> 20 ng/ml * g. Regional pathologic nodes or metastases * h. Androgen-deprivation therapy * i. Any cancer within the last 5 years except skin basocellular carcinoma or any uncontrolled cancer * j. Urethral stenosis * k. Recurrent prostatitis (at least 3 episodes within the last 3 years) * l. Any inflammatory collagen disease. * m. Contraindication to repeated prostatic biopsies or MRI

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Capra score ≤5 Macroscopic tumor visualized at mri Tumor size allowing partial prostate treatment volume

How to take part

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

The places running it

2 sites. 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.

Could a quick radiation shot keep prostate cancer in check without surgery?

What the study statuses mean