Intermediate risk prostate cancer
Conditions
Brief summary
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.
Detailed description
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], 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), Rate of patients experiencing non pathological fracture at 2 years, Rate of cardiovascular events at 48 weeks (myocardial infarction and stroke), Erectile disfunction rate measured with IIEF at 2 years after the end of treatment, Quality of life measured with EORTC QLQ-C30 and EORTC QLQ-PR25
Interventions
DRUGRELUGOLIX
Sponsors
Fondazione Radioterapia Oncologica Onlus
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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], 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), Rate of patients experiencing non pathological fracture at 2 years, Rate of cardiovascular events at 48 weeks (myocardial infarction and stroke), Erectile disfunction rate measured with IIEF at 2 years after the end of treatment, Quality of life measured with EORTC QLQ-C30 and EORTC QLQ-PR25 | — |
Countries
Italy
Outcome results
None listed