Evaluation of the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (= 70 years) with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen (CABASTY)
- Conditions
- Metastatic castration-resistant prostate cancer (mCRPC)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001179-60-NL
- Lead Sponsor
- A.R.T.I.C (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 170
1.Patient aged = 70 years with mCRPC previously treated with docetaxel
2.Medical or surgical castration with castrate level of testosterone (< 50 ng/dl)
3.Progressive disease according to physician judgement
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method