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New trial aims to halt spread of aggressive prostate cancer with precision radiation

NCT ID NCT07426094

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This clinical trial is for men with prostate cancer that has spread to nearby pelvic lymph nodes but not further. It compares two radiation strategies: one that gives a higher dose to the prostate only, and another that boosts both the prostate and the affected lymph nodes. All participants receive whole-pelvis radiation and hormone therapy. The goal is to see which approach better prevents the cancer from spreading to distant parts of the body.

What this could mean

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

Active substance
Ultrahypofractionated whole-pelvis radiotherapy with optional prostate boost (via brachytherapy or SBRT) and nodal boost
What this could lead to
If successful, this trial could show the best way to intensify radiotherapy for node-positive prostate cancer, potentially improving metastasis-free survival and guiding future treatment standards.
What could go wrong
This is an early-to-mid-stage trial (phase II/III) with 1600 participants, and results may not confirm superiority of one approach. Long-term androgen deprivation therapy is required, and side effects from intensified radiation could be significant.

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 600 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: * Histologically confirmed adenocarcinoma of the prostate. * Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease. * Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and/or PSMA PET/CT. * No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases. * Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes. * Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy. * Age ≥18 years. * Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: * Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases. * Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy. * Prior pelvic radiotherapy for any indication that would overlap planned treatment fields. * Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy. * History of castration-resistant prostate cancer. * Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes. * Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy. * Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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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