Can a precise radiation boost beat prostate cancer relapse?

NCT ID NCT07343349

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial is testing two improvements to standard radiation therapy for men with high-risk prostate cancer. First, it adds a higher radiation dose (a boost) directly to the visible tumor inside the prostate, aiming to reduce the chance of cancer spreading. Second, it compares giving the radiation in 12 sessions versus 20 sessions to see if fewer treatments are just as safe and effective. About 1,000 men will take part, and the main goal is to see if the boost helps prevent distant metastases.

What this could mean

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

Active substance: radiation therapy (focal boost and hypofractionation)
What this could lead to: If successful, this could mean better control of high-risk prostate cancer with fewer hospital visits, reducing the chance of cancer spread and the need for hormone therapy.
What could go wrong: This is a large but still ongoing trial, so results are not yet known. The boost might increase side effects, and the shorter treatment schedule might not be as effective as the standard one.

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

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 1,016 people

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

Started

Dec 2025

Expected to finish

Oct 2040

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

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: * Patients with biopsy verified PCa with no distant metastases with either * Intermediate- or high-risk PCa, defined as at least one of the following risk criteria: * Clinical stage cT2c-T3b (UICC TNM 8th edition) * Imaging stage, T3a or T3b * ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5) * Regional lymph node metastases N1 * Age \> 18 * WHO score 0-1 * Intraprostatic lesion visible on MRI * Suitable for focal boost * Ability to give written informed consent and willingness to return for follow-up Exclusion Criteria: * WHO performance status ≥ 2 * If, for any patient related reason, an MRI cannot be performed * T4 * International prostate symptom score (IPSS) ≧ 20 * If fiducial markers cannot be inserted * TURP within 3 months from start of treatment * Previous pelvic irradiation * If the patient is judged by the physician to be unable to adhere to trial activities * History of chronic inflammatory bowel disease (CIBD)

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

High risk localised prostate carcinoma Locally advanced prostate cancer Prostate cancer patients undergoing external radiation and seed implantation Unfavourable intermediate risk prostate cancer

How to take part

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

The places running it

3 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.

Can a precise radiation boost beat prostate cancer relapse?

What the study statuses mean