Efficacy Study Evaluating Chemotherapy in Prostate Cancer (SensiCab)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological confirmed prostate adenocarcinoma Metastatic PC (Prostate cancer) with measurable or evaluable disease or High risk PC (PSA > 100) or Node positive disease (N+)
- No prior treatment for prostate cancer (including bisfosfonate)
- Age above 18 years
- ECOG 0- 2
- Estimated survival > 3 months
- WBC 2000 / mm 3, neutrophils ≥1500 / mm 3, platelets 100,000 / mm 3
- Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal.
- Satisfactory renal function. Serum creatinine <1.5 x ULN (150 mmol/l). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted in the study. https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr
- Patient information and signature of informed consent
Exclusion Criteria:
- Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)
- Severe peripheral neuropathy
- Active infection or other serious underlying pathology that could prevent patients from receiving treatment
- History of cancer within 5 years before inclusion in the study other than basal cell or squamous cell skin cancer adequately treated
- Brain metastases, uncontrolled symptomatic or asymptomatic
- Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization.
- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
- Systemic treatment with high dose steroids
- Any severe acute or chronic medical condition which would 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.
- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
Sites / Locations
- University Hospital of ÖrebroRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A:
Arm B:
Cabazitaxel 25 mg / m² / day on day 1 every 3 weeks continued if the patient has stable disease or responding to up to 10 cycles. Cabazitaxel will be administered in combination with oral prednisone or prednisolone (Prednisolon 10mg 1x1) Hormones will be initiated in conjunction with the last cycle of chemotherapy. Consists of the administration of a luteinizing hormone-releasing hormone (LHRH) agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device. G-CSF treatment according to ASCO guidelines is recommended.
-Hormone: LHRH agonist antiandrogens for 30 days + OR surgical castration OR CAB complete androgen blockade by LHRH agonist + antiandrogen device.