RELUGOLIX for Intermediate risk prostate cancer

Inclusion criteria

• {"criterion_text":"- > 18 years old"}
• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- Hystological confirmation of prostate adenocarcinoma"}
• {"criterion_text":"- Deemed suitable for ultrahypofractionated treatment on prostate (IPSS < 15, prostate volume <90 cc)"}
• {"criterion_text":"- Patients should be candidate to androgen deprivation therapy for the management of prostate cancer"}
• {"criterion_text":"- Unfavourable intermediate risk (GLeason 4+3 and or >50% of biopsy cores positive and or > 2 intermediate risk factor)"}

Exclusion criteria

• {"criterion_text":"- Neuroendocrine differentiation"}
• {"criterion_text":"- 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.)"}
• {"criterion_text":"- Any high-risk feature (Gleason >4+3, >cT3a, PSA > 20 ng/ml)"}
• {"criterion_text":"- Any contrahindication for ultrahypofractionated radiotherapy on prostate"}
• {"criterion_text":"- Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months"}
• {"criterion_text":"- Active conduction system abnormalities"}
• {"criterion_text":"- Uncontrolled hypertension"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Complete biochemical response defined in-text as PSA <0.5 ng/ml measured at 6 months after treatment."}

Secondary endpoints

• {"endpoint_text":"- Biochemical relapse free survival (BRFS) at 2 years after end of radiotherapy. Biochemical relapse will be defined as a rise by 2 ng/mL or more above the nadir PSA according to RTOG- ASTRO Phoenix Consensus Conference [Roach 2006]","definition_or_measurement_approach":"BRFS defined as rise by 2 ng/mL or more above nadir PSA per RTOG-ASTRO Phoenix criteria; measured at 2 years after end of radiotherapy."}
• {"endpoint_text":"- Rate of patients with testosterone recovery at 90 days from the end of ADT treatment (eugonadal level of testosterone will be defined as >150 ng/dL)","definition_or_measurement_approach":"Testosterone recovery defined as >150 ng/dL measured 90 days from end of ADT treatment."}
• {"endpoint_text":"- Rate of patients experiencing non pathological fracture at 2 years","definition_or_measurement_approach":"Incidence of non-pathological fractures assessed up to 2 years."}
• {"endpoint_text":"- Rate of cardiovascular events at 48 weeks (myocardial infarction and stroke)","definition_or_measurement_approach":"Incidence of myocardial infarction and stroke assessed through 48 weeks."}
• {"endpoint_text":"- Erectile disfunction rate measured with IIEF at 2 years after the end of treatment","definition_or_measurement_approach":"Erectile dysfunction rate measured using IIEF questionnaire at 2 years post-treatment."}
• {"endpoint_text":"- Quality of life measured with EORTC QLQ-C30 and EORTC QLQ-PR25","definition_or_measurement_approach":"Quality of life assessed using EORTC QLQ-C30 and QLQ-PR25 questionnaires."}

Italy

Earliest CTIS Part Ii Submission Date

10-03-2025

Latest Decision Or Authorization Date

03-04-2025

Processing Time Days

24

Number Of Sites

14

Number Of Participants

73

Primary sponsor

Full Name

Fondazione Radioterapia Oncologica Onlus

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy