PATIENTS WITH BONE METASTASIS FROM PROSTATIC CARCINOMA MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 CT/RMN, 4. Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2 5. Expected life expectancy = 3 months, 6. Patients who have already received docetaxel, cabazitaxel and at least one next generation hormonal agent (abiraterone or enzalutamide) for metastatic disease (either hormone sensitive or castration resistant), 7. Subject capable to swallow the Study's medication and to comply with the Study's requirements, 8. Fertile patients and their partners must agree to use methods of contraception. 9. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make 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) 1,5 x ULN at Screening Visit, 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x ULN at Screening Visit, 7. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit, 8. Albumin = 30 g/L (= 3,0 g/dL) at Screening Visit, 9. Alkaline Phosphatase = 5 x ULN, 10. Prothrombin time / international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test = 1.3 x the laboratory ULN, 11. Urine protein-to-creatinine ratio (UPCR) > 1 mg/mg (or 113.0 mg/mmol) or proteinuria > 1 g/24 h, 12. 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, 13. Clinically significant cardiovascular disease including - Myocardial infarction - Uncontrolled angina - 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 - History of long QT syndrome or corrected QT interval calculated by the Fridericia formula > 500 msec at Screening Visit, - History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, - Hypotension as indicated by systolic blood pressure 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit, 14. Gastrointestinal disorder affecting absorption 15. Major surgery within 4 weeks of enrollment 16. Concomitant therapy with anticoagulants ,17. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease 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 18. Bone antiresorptive drugs that are started within 4 weeks of enrollment Bone antiresorptive drugs are permitted if already ongoing before this time point. Patients will be stratified according to zoledronic acid/denosumab exposure. 19. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment or radiotherapy on sites other than bone administrated within 4 weeks of enrollment (Day 1 Visit). Radiotherapy on bone administrated within 2 weeks of enrollment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiotherapy given with palliative intent will be permitted during study treatment. 20. Any condition or reason that, i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of bone response to Cabozantinib treatment through WB-DW-MRI.;Secondary Objective: Changes in: ¿ BMD and TBS through DXA scan bone metabolism markers: CTX, bone alkaline phosphatase bone pain with validated pain questionnaires (Brief Pain Inventory) SRE and Quality of Life evaluation (FACT-P questionnaire) uptake at bone scan body composition: FBM, LBM through DXA scan Correlation between: disease response with DW-MRI and bone scan changes disease response with DW-MRI and bone pain variation changes in bone mineral density and TBS changes in either bone mineral density or TBS and markers of bone metabolism;Primary end point(s): Evaluation of bone response to Cabozantinib treatment through WB-DW-MRI.;Timepoint(s) of evaluation of this end point: 2-3-6-12- Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in: BMD and TBS through DXA scan bone metabolism markers: CTX, bone alkaline phosphatase bone pain with validated pain questionnaires (Brief Pain Inventory) SRE and Quality of Life evaluation (FACT-P questionnaire) uptake at bone scan body composition: FBM, LBM through DXA scan; Correlation between: disease response with DW-MRI and bone scan changes disease response with DW-MRI and bone pain variation changes in bone mineral density and TBS changes in either bone mineral density or TBS and markers of bone metabolism;Timepoint(s) of evaluation of this end point: 3-6-12 month; 3-6-12 month | — |
Countries
Italy
Contacts
Public Contactprogettazione ricerca e studi di fa
azienda socio sanitaria territoriale degli spedali civili di brescia
Outcome results
None listed