Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (* 65 years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (CABASTY).
- Conditions
- Prostate cancer10038597
- Registration Number
- NL-OMON48773
- Lead Sponsor
- ARTIC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
1. Patient aged * 65 years with mCRPC previously treated with docetaxel
2. Medical or surgical castration with castrate level of testosterone (< 50
ng/dl) based on the EAU definition of castrate level of testosterone
3. Progressive disease according to PCWG2 (Appendix H)
4. Histologically proven prostate carcinoma
5. Health status allowing use of chemotherapy: G8 > 14; or G8 score * 14 with
geriatric assessment concluding to reversible impairment allowing use of
chemotherapy
6. ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)
7. Adequate hematologic, liver and renal functions:
a) Neutrophil count *1.5 109/L
b) Haemoglobin *10 g/ dL
c) Platelet count *100.109/L
d) Total bilirubin * 1 the upper limit of normal (ULN)
e) Transaminases * 1.5 ULN
f) Serum creatinine * 2.0 ULN
8. Ongoing LHRH therapy at study entry
9. Signed informed consent
1.History of severe hypersensitivity reaction (.grade 3) to docetaxel
2.History of severe hypersensitivity reaction (.grade 3) to polysorbate 80
containing drugs
3.Uncontrolled severe illness or medical condition (including uncontrolled
diabetes mellitus)
4.Concurrent or planned treatment with strong inhibitors or strong inducers of
cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who
are already on these treatments) (see Appendix E)
5.ECOG-PS >2 not related to prostate cancer disease
6.G8 . 14 with geriatric assessment contra-indicating standard cabazitaxel
regimen
7.Concomitant vaccination with yellow fever vaccine
8.Patient who cannot be regularly followed or cannot answer to quality of life
questionnaires because of psychological, social, familial or geographic reasons
9.Participation in another clinical trial with any investigational drug within
30 days prior to study enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Grade *3 neutropenia (measured at D7 and D14 of each cycle) and/or neutropenic<br /><br>complications (febrile neutropenia, neutropenic infection or sepsis) during the<br /><br>overall treatment period</p><br>
- Secondary Outcome Measures
Name Time Method