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Shorter hormone therapy meets precision radiation in High-Risk prostate cancer

NCT ID NCT06772441

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether men with high-risk localized prostate cancer can safely receive a shorter course of hormone therapy alongside focused, dose-escalated radiation to the prostate. The trial enrolls 30 men and uses an AI-based classifier to help tailor treatment. All participants receive 12 months of androgen deprivation therapy plus five high-dose radiation sessions, with the goal of controlling cancer while reducing hormone-related side effects.

What this could mean

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

Active substance
androgen deprivation therapy with goserelin plus dose-escalated radiotherapy
What this could lead to
If it works, this approach could offer men with high-risk prostate cancer a shorter course of hormone therapy and fewer side effects while still controlling the cancer.
What could go wrong
This is a small, single-arm phase 2 study with 30 participants, so it cannot prove the treatment is better than standard care. The cancer may return, and the radiotherapy and hormone therapy can cause urinary, bowel, and sexual side effects.

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

Nov 2024

Expected to finish

Oct 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: 1. 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) 2. Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI) 3. High-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \> 20 ng/ml) 4. Signed written informed consent for this study 5. Age \>18 years 6. Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR 7. MMAI low-/intermediate-risk 8. ECOG Performance score 0 or 1 9. IPSS Score ≤15 10. Prostate biopsy core with the highest ISUP grade available Exclusion Criteria: 1. Prior radiotherapy to the prostate or pelvis 2. Prior radical prostatectomy 3. Prior focal therapy approaches to the prostate 4. Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT 5. Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT 6. Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is \>2 months 7. Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT 8. PSA \>50 ng/ml prior to starting of systemic therapy 9. Expected patient survival \<5 years 10. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts 11. Contraindication to undergo a MRI scan 12. Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anaesthesia) 13. Contraindication to Goserelin 14. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization 15. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia 16. 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 17. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis 18. Participation in any other interventional clinical trial within the last 30 days before the start of this trial 19. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 20. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial; 21. Known or persistent abuse of medication, drugs or alcohol 22. Patients expected to have severe set up problems (e.g. mental condition)

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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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