Shorter hormone therapy meets precision radiation in High-Risk prostate cancer
NCT ID NCT06772441
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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German Oncology Center
RECRUITINGLimassol, 4108, Cyprus
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?