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Ultra-hypofractionated radiotHErapy and concomitant oral RelugOlix for treatment of intermediate risk prostate cancer. (Ultra-HERO trial)
EU CTIS ID: 2024-518388-37-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- > 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)
You likely can't join if
- Neuroendocrine differentiation
- 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.)
- Any high-risk feature (Gleason >4+3, >cT3a, PSA > 20 ng/ml)
- 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
- Active conduction system abnormalities
See the full eligibility criteria
- > 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)
- Neuroendocrine differentiation
- 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.)
- Any high-risk feature (Gleason >4+3, >cT3a, PSA > 20 ng/ml)
- 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
- Active conduction system abnormalities
- Uncontrolled hypertension
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.