Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer

NCT ID NCT06582446

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing a treatment plan for men with high-risk localized prostate cancer that combines whole-pelvis radiation given in five sessions, a high-dose radiation boost directly to the prostate, and two years of androgen deprivation therapy. The study aims to see how often urinary side effects occur and whether the approach controls the cancer. About 30 men will take part, and researchers will also track whether an artificial intelligence tool can predict outcomes.

What this could mean

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

Active substance
a combination of whole-pelvis radiation, a high-dose radiation boost to the prostate, and two years of androgen deprivation therapy
What this could lead to
If it works, this approach could offer a shorter, five-fraction radiation schedule that controls high-risk prostate cancer while keeping urinary side effects manageable.
What could go wrong
The trial is small and single-arm, so it cannot prove the regimen is better than standard treatment. Radiation to the pelvis can cause urinary, bowel, or sexual side effects, and two years of hormone therapy carries its own risks.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

Sep 2024

Expected to finish

Aug 2027

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 (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old) * Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI) * High- or very high-risk according to NCCNv1.2023 criteria * Signed written informed consent for this study * Age \>18 years * Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR * MMAI high-risk * ECOG Performance score 0 or 1 * IPSS Score ≤15 Exclusion Criteria: * Prior radiotherapy to the prostate or pelvis * Prior radical prostatectomy * Prior focal therapy approaches to the prostate * Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT * Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT * Time gap between the beginning of any systemic therapyADT and conduction of PSMA-PET scans is \>2 months * Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT * PSA \>50 ng/ml prior to starting of systemic therapy * Expected patient survival \<5 years * Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts * Contraindication to undergo a MRI scan * Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anesthesia) * Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization * Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia * Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival * Any other contraindication to external beam radiotherapy (EBRT) to the pelvis * Participation in any other interventional clinical trial within the last 30 days before the start of this trial * Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed * Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial * Known or persistent abuse of medication, drugs or alcohol

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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

  • German Oncology Center

    RECRUITING

    Limassol, 4108, Cyprus

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