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Can a targeted radiation boost improve prostate cancer control?

NCT ID NCT07792993

Disease control Sponsor: Regina Elena Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This study tests whether giving an extra, focused dose of radiation to the main tumor inside the prostate can improve cancer control in men with intermediate- or high-risk localized prostate cancer. Participants receive standard moderately hypofractionated radiotherapy (62 Gy in 20 sessions) plus a micro-boost up to 71.3 Gy to MRI-visible lesions. The main goal is to see if this approach improves the rate of being free from biochemical recurrence at 3 years, while keeping side effects manageable.

What this could mean

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

Active substance
moderately hypofractionated radiotherapy with a focal micro-boost to MRI-visible prostate lesions
What this could lead to
If it works, this approach could improve the chance of keeping prostate cancer under control after radiotherapy, without adding significant side effects.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The boost might increase side effects, and the benefit may not be confirmed in larger studies.

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.

Participants

About 82 people

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

Started

Aug 2025

Expected to finish

Jun 2028

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.

Who is studied

The study population includes adult patients with histologically confirmed prostate adenocarcinoma who are eligible for moderately hypofractionated radiotherapy in 20 fractions and have at least one MRI-visible lesion suitable for focal boosting. Patients must have intermediate or high-risk prostate cancer according to NCCN risk stratification. Unfavourable intermediate-risk disease includes patients without high-risk features but with two or three intermediate-risk factors, Grade Group 3 disease and/or more than 50% positive biopsy cores. Intermediate-risk factors include clinical stage T2b-T2c, Grade Group 2-3 and PSA between 10 and 20 ng/mL. High-risk disease includes clinical stage T3a, Grade Group 4-5 or PSA greater than 20 ng/mL.

Ages

18 to 99 years

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: * Age 18 years or older. * Histologically confirmed diagnosis of prostate adenocarcinoma. * Intermediate or high-risk prostate cancer according to NCCN criteria. * No regional or distant metastases. * ECOG performance status 0-1. * Eligibility for moderately hypofractionated radiotherapy in 20 fractions. * Presence of at least one PI-RADS 4 or 5 lesion on multiparametric MRI, or a PI-RADS 3 lesion confirmed as positive at pathology. * Ability to understand the Italian language and adhere to study procedures. * Written informed consent for participation and data processing. Exclusion Criteria: * Previous local prostate treatment with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy. * Previous pelvic radiotherapy. * Presence of nodal or distant metastases confirmed by MRI or PET/CT.

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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.

Localized prostate cancer

How to take part

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

  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • IRCCS Regina Elena National Cancer Institute

    RECRUITING

    Rome, Lazio, 00144, Italy

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