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Bone Response After Luteinizing Hormone-releasing Hormone Analogue and Enzalutamide +/- Zoledronic Acid in Prostate Cancer Patients With Hormone Sensitive Metastatic Bone Disease: a Prospective, Phase II, Randomized, Multicenter Study - BonEnza

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Linee di trattamento: Prima linea

Criteri di inclusione: 

1. Histological diagnosis of prostate carcinoma,
2. Age > 18 years,
3. Metastatic disease documented as the presence of bone lesions on bone scan associated or not to soft tissue lesions measurable at computed tomography (CT) scan or Magnetic Resonance Imaging (MRI),
4. No previous hormone or chemotherapeutic treatments given for prostate carcinoma (patients that are receiving LHRH-A therapy for less than 4 months are admitted),
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1,
6. Expected life expectancy ≥ 6 months,
7. Subject capable to swallow the Study's medication and to comply with the Study's requirements,
8. Signed informed consent

Criteri di esclusione: 

1.Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make (at the discretion of the clinical Investigator),
2. Known or suspected brain metastases or active leptomeningeal dissemination,
3. History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
4. Absolute Neutrophil Count (ANC) < 1.500/µL, platelet < 100.000/µL, or hemoglobin < 5,6 mmol/L (< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x upper limit of normal (ULN) at Screening Visit,
6. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit,
7. Albumin ≤ 30 g/L (≤ 3,0 g/dL) at Screening Visit,
8. History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
9. Clinically significant cardiovascular disease including:
    - myocardial infarction (6 months preceding the screening)
    - uncontrolled angina (3 months preceding the screening)
    - Congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
    - History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
    - History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
    - Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit;
    - Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG;
    - Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit;
10. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
11. Major surgery within 4 weeks of enrollment (Day 1 Visit);
12. Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit);
13. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease Prostate-specific antigen (PSA) levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit);
14. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

Trattamento sperimentale: 

LHRH-A + Enzalutamide
LHRH-A + Enzalutamide + Zoledronic Acid

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Evaluation of change in bone response after 6 and 12 months of treatment compared to baseline [ Time Frame: Exam will be performed at baseline and after 6 and 12 months of treatment ]
Whole-body Diffusion MRI

Centri partecipanti

Nord Italia

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

 

Azienda Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

Riferimento: Prof. Alfredo Berruti
Telefono: 0303995410
Email: alfredo.berruti@gmail.com

 

Azienda Ospedaliera Carlo Poma
Via Albertoni 1 - 46100 Mantova - MN

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-000305-21

Data di inserimento: 04.06.2019

Promotore

Azienda Ospedaliera Spedali Civili di Brescia

CRO

NA

Principal Investigator ITALIA

Spedali Civili Brescia

Riferimento: Prof. Alfredo Berruti

Telefono: 0303995410

Email: alfredo.berruti@gmail.com

Localita: Brescia

 

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