SYF3a1144db706e49f3a796d85dbd234ebfRegistry ID: 2024-518388-37-00|Not Yet RecruitingPhase 2
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interventional
N/A
1 country
14
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.
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Not reported
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December 19, 2024
Actual (reported)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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Azienda Ospedaliero Universitaria Parma
Parma, 43126, Italy
Cliniche Gavazzeni S.p.A.
Bergamo, 24125, Italy
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Messina, 98124, Italy
Lorenzo Livi
First Submitted
December 19, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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VAccination in Early and ADvanced Prostate caNCEr
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Casa Di Cura Macchiarella S.p.A.
Palermo, 90138, Italy
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, 42123, Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, 41124, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, 10126, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Centro Di Riferimento Oncologico Di Aviano
Aviano, 33081, Italy
Ospedale Isola Tiberina Gemelli Isola
Rome, 00186, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, 37024, Italy
ARNAS Civico Di Cristina Benfratelli
Palermo, 90127, Italy
Humanitas Mirasole S.p.A.
Rozzano, 20089, Italy