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XL184315 - A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Men with histologically or cytologically confirmed adenocarcinoma of the prostate
- Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or mCSPC, M0 CRPC, or mCRPC
- Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening
- Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
- Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
- Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the day of consent
- ECOG performance status of 0 or 1
- Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
- Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization
- Understanding and ability to comply with protocol requirements

Criteri di esclusione: 

- Any prior nonhormonal therapy initiated for the treatment of mCRPC
- Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
- Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible)
- Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
- Symptomatic or impending spinal cord compression or cauda equina syndrome
- Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
- Administration of a live, attenuated vaccine within 30 days prior to randomization
- Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
- Uncontrolled, significant intercurrent or recent illness
- Major surgery within 4 weeks prior to randomization
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG within 21 days before randomization
- Inability or unwillingness to swallow pills or receive IV administration
- Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
- Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).

Trattamento sperimentale: 

Cabozantinib + Atezolizumab

Trattamento di controllo: 

EITHER abiraterone + prednisone OR enzalutamide

Centri partecipanti

Nord Italia

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Ugo De Giorgi
Telefono: 0543739100
Email: ugo.degiorgi@irst.emr.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Prof. Andrea Necchi
Telefono: 0226435789
Email: necchi.andrea@unisr.it

 

IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV
N.B.: Arruolamento pazienti non ancora attivo

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
N.B.: Arruolamento pazienti non ancora attivo

 

AO della Valtellina e Valchiavenna
Via Stelvio 25 - 23100 Sondrio - SO
N.B.: Arruolamento pazienti non ancora attivo

 

Presidio ospedaliero di Santa Chiara
Largo Medaglie d'Oro 1 - 38122 Trento - TN
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Orazio Caffo
Telefono: 0461902121
Email: orazio.caffo@apss.tn.it

 

Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Prof.ssa Rossana Berardi
Telefono: 0715964169
Email: Rossana.Berardi@ospedaliriuniti.marche.it

 

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

Riferimento: Prof. Lorenzo Antonuzzo
Telefono: 0557947298
Email: antonuzzol@aou-careggi.toscana.it

 

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Roberto Iacovelli
Telefono: 0630154953
Email: roberto.iacovelli@policlinicogemelli.it

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Dr. Giuseppe Simone
Telefono: 0652666962
Email: Giuseppe.simone@ifo.it

 

AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Sergio Bracarda
Telefono: 0744205631
Email: s.bracarda@aospterni.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT04446117

Data di inserimento: 11.05.2022

Promotore

Exelixis

Principal Investigator ITALIA

IRCCS Istituti Fisioterapici Ospitalieri 'Regina Elena'

Riferimento: Dr. Giuseppe Simone

Telefono: 0652666962

Email: Giuseppe.simone@ifo.it

Localita: Roma

 

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