2024-518388-37-00Not yet recruitingPhase 2
Ultra-hypofractionated radiotHErapy and concomitant oral RelugOlix for treatment of intermediate risk prostate cancer. (Ultra-HERO trial)
Ultra-hypofractionated radiotHErapy and concomitant oral RelugOlix for treatment of intermediate risk prostate cancer. (Ultra-HERO)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Jun 2026
Brief summary (registry, in English)
To assess rate of complete biochemical response after 6 months of treatment, defined as PSA <0.5 ng/ml, in an homogeneous cohort of patients affected by unfavourable intermediate risk localized prostate cancer undergoing prostate radiotherapy (36.25 GY in 5 fractions) + short course oral relugolix.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 3 Mar 2025
- Lead sponsor
- Fondazione Radioterapia Oncologica Onlus
- Diseases
- Prostate cancer
- EU CT number
- 2024-518388-37-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 73
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has not spread and is at unfavourable intermediate risk. They would have short radiotherapy plus relugolix tablets.
- Age
- Over 18 years old.
- Sex
- Men only.
- Disease stage
- Prostate adenocarcinoma confirmed by biopsy, localized, unfavourable intermediate risk (Gleason 4+3 and/or more than 50% of biopsy cores positive and/or more than 2 intermediate risk factors).
- Earlier treatment
- People must be candidates for androgen deprivation therapy. They must be able to have ultra-hypofractionated radiotherapy of the prostate (IPSS < 15, prostate volume < 90 cc).
Main reasons for not taking part
- Neuroendocrine differentiation
- Metastatic disease at diagnosis
- Any high-risk feature (Gleason >4+3, >cT3a, PSA > 20 ng/ml)
- Heart attack, unstable heart disease or stroke in the past 6 months
- Uncontrolled hypertension
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contrahindication for ultrahypofractionated radiotherapy on prostate
- Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months
Other illness
- Metastatic disease at diagnosis (Patients will be staged with conventional imaging consisting of CT and/or bone scan and prostate MRI. PSMA imaging is allowed but not mandatory.)
- Uncontrolled hypertension
Other
- Neuroendocrine differentiation
- Any high-risk feature (Gleason >4+3, >cT3a, PSA > 20 ng/ml)
- Active conduction system abnormalities
Who the study is looking for
- > 18 years old
- Signed informed consent
- Hystological confirmation of prostate adenocarcinoma
- Deemed suitable for ultrahypofractionated treatment on prostate (IPSS < 15, prostate volume <90 cc)
- Patients should be candidate to androgen deprivation therapy for the management of prostate cancer
- Unfavourable intermediate risk (GLeason 4+3 and or >50% of biopsy cores positive and or > 2 intermediate risk factor)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano | Aviano | Italy | Not yet recruiting |
| Cliniche Gavazzeni S.p.A. | Bergamo | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina | Messina | Italy | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Not yet recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Italy | Not yet recruiting |
| ARNAS Civico Di Cristina Benfratelli | Palermo | Italy | Not yet recruiting |
| Casa Di Cura Macchiarella S.p.A. | Palermo | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Parma | Parma | Italy | Not yet recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Not yet recruiting |
| Ospedale Isola Tiberina - Gemelli Isola | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.