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Major trial tests best way to boost radiation for prostate cancer

NCT ID NCT07426055

Disease control Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 22, 2026 · Updated 4 times

Summary

This study is testing whether adding a focused radiation boost after standard short-course radiotherapy improves outcomes for men with localized prostate cancer. About 1,200 men will be randomly assigned to receive either standard SBRT alone or SBRT plus one of three boost methods: HDR brachytherapy, LDR brachytherapy, or an extra SBRT dose. The goal is to find which approach best prevents cancer recurrence while limiting side effects on urinary, bowel, and sexual function.

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 (SBRT, HDR brachytherapy, LDR brachytherapy, and external beam radiotherapy)
What this could lead to
If successful, this trial could show which radiation approach best controls prostate cancer while minimizing side effects, helping doctors choose the optimal treatment for future patients.
What could go wrong
This is a large, late-phase trial, but all treatments are already standard—so the benefit may be modest. Long follow-up is needed, and results may not apply to all prostate cancer types.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,000 people

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

Started

Mar 2026

Expected to finish

Dec 2035

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: * Male patients aged ≥18 years. * Histologically confirmed adenocarcinoma of the prostate. * Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0. * Negative pelvic nodal and distant metastatic disease on baseline PSMA PET. * NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease. * Candidate for definitive radiotherapy with curative intent. * ECOG performance status 0-2. * Baseline PSA available prior to randomization. * Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol. * Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group. * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging. * Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy. * Prior pelvic radiotherapy for any malignancy. * Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT. * History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer). * Contraindications to radiotherapy or anesthesia required for brachytherapy procedures. * Severe uncontrolled comorbidities that would preclude protocol treatment. * Inability to comply with study procedures or follow-up schedule.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

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

Dose escalation: solid tumors Localized prostate cancer Prostate brachytherapy Prostate cancer (adenocarcinoma) Stereotactic body radiation therapy (SBRT)

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

  • Affidea Nu-Med, Center of Oncological Diagnostics and Therapy

    RECRUITING

    Zamość, Lublin Voivodeship, 22-400, Poland

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