Metastatic Castration Resistant Prostate Cancer (mCRPC) progressed during or after a previous docetaxel-based chemotherapy. MedDRA version: 21.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl
Conditions
Interventions
Trade Name: JEVTANA - 60MG-CONCENT. E SOLV.PER SOLUZ. PER INFUSIONE-USO ENDOVENOSO -CONCENT.:FLACONC.(VETRO)SOLV.: FLACONC.(VETRO)-CONCENT.:1.5ML SOLV.:4.5ML-1FLAC.+1FLAC.
Pharmaceutical Form: Concent
Sponsors
CONSORZIO ONCOTECH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Histological diagnosis of prostate adenocarcinoma; 3. Metastatic castration-resistant disease with documented radiographic progression (osseous or measurable lesions) during or after a docetaxel-based chemotherapy; 4. Testosterone level in the castration range (levels 18 years; 8. ECOG performance status 0-2; 9. ANC = 1.5 x 109/L; 10. PLT = 100 x 109/L; 11. Hb = 10 g/dl; 12. Serum total bilirubin = UNL; 13. AST/SGOT and/or ALT/SGPT =1,5 x ULN; 14. Serum Creatinine =1,5 times UNL (in case of limit values of serum creatinine, creatinine clearance calculated by CKD-EPI formula should be =60 ml/min); 15. PT or INR and PTT =65 years) yes F.1.3.1 Number of subjects for this age range 154
Exclusion criteria
Exclusion criteria: 1. Participation in clinical trials with other investigational drug within 28 days of study entry; 2. Symptomatic or uncontrolled brain metastases. Patients with neurological symptoms must undergo a computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis; previously treated brain metastases will be allowed as long as the patient is neurologically stable and does not require steroids and anticonvulsants; 3. Less than 4 weeks elapsed from prior anticancer-therapy or surgery to the time of randomization. Patient may be on bisphosphonates prior to study entry. Prior treatment with abiraterone or enzalutamide is allowed and is used as a stratification factor at randomization. Patient may be on biphosphonates prior to study entry; 4. Less than 4 weeks from palliative Radiotherapy to time of randomization; 5. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, pulmonary embolism or other uncontrolled thromboembolic event; 6. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures; 7. Unstable diabetes mellitus, resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, acute diverticulitis or other contraindications to use of corticosteroid treatment; 8. Peripheral neuropathy Grade > 2 (National Cancer Institute Common Terminology Criteria (NCI CTCAE v.4.03); 9. Previous beta or gamma Isotope treatment (e.g. strontium or samarium), alpha emitters are allowed; 10. History of severe hypersensitivity reaction (> grade 2) to polysorbate 80 containing drugs; 11. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week washout period is necessary for patients who are already on these treatments); 12. Previous malignancy except for basal cell or squamous cell skin cancer adequately treated, or any other cancer from which the patient has been disease-free for = 5 years; 13. Patients with reproductive potential who do not agree to use accepted and effective method of contraception, based on the investigator’s judgment, during the study treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether cabazitaxel alone is non inferior in terms of radiographic PFS with respect to cabazitaxel plus daily prednisone in patients with castration resistant prostate cancer.;Secondary Objective: •Safety in the two treatment arms; •Health-Related Quality of Life (HRQL) and pain; •Objective Response Rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); •Biochemical response (assessed considering PSA decrease =50% and waterfall plot results); •Time to PSA Progression (TTPP); •Radiographic Time to Progression (rTTP); •Overall Survival (OS); •Association of Overal Survival (OS), Progression Free Survival (PFS) and Objective Response Rate (ORR) with AR-V7 and RB status in circulating tumor cells assessed at flow-cytometry; •Time to Skeletal-Related Event (SRE);;Primary end point(s): Radiographic Progression-Free Survival (rPFS);Timepoint(s) of evaluation of this end point: Screening, and then every 9 weeks for the first 18 weeks, then every 12 weeks, until radiographic tumor progression is documented or study cut-off. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: every 4 weeks; They will be evaluated at Screening and every 4 weeks of treatment.; Results must be available prior to each cycle of treatment; Defined as the time interval from the date of randomization to the date of death due to any cause. ; The test will be performed at baseline; every 4 weeks.;Secondary end point(s): Safety in the two treatment arms;; Health-Related Quality of Life HRQL and pain; Objective Response Rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1).; Biochemical response (PSA decrease =50%); Overall Survival (OS); AR-V7 and RB status in circulating tumor cells by the use of Adna test.; Time to Skeletal-Related Event (SRE). | — |
Countries
Italy
Contacts
Public ContactMedical monitoring
Carlo Buonerba
Outcome results
None listed