RANDOMIZED, OPEN LABEL, MULTI-CENTER STUDY COMPARING CABAZITAXEL AT 25 MG/M2 AND AT 20 MG/M² IN COMBINATION WITH PREDNISONE EVERY 3 WEEKS TO DOCETAXEL IN COMBINATION WITH PREDNISONE IN PATIENTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER NOT PRETREATED WITH CHEMOTHERAPY
- Registration Number
- PER-016-11
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 10
101. HISTOLOGICALLY OR CYTOLOGICALLY-CONFIRMED PROSTATE ADENOCARCINOMA.
102. METASTATIC DISEASE.
103. PROGRESSIVE DISEASE WHILE RECEIVING HORMONAL THERAPY OR AFTER SURGICAL CASTRATION DOCUMENTED BY AT LEAST ONE OF THE FOLLOWING:
A) INCREASE IN MEASURABLE DISEASE (RECIST 1.1) (8), AND/OR
B) APPEARANCE OF NEW LESIONS, INCLUDING THOSE ON BONE SCAN (2:2 NEW LESIONS ON 2 CONSECUTIVE BONE SCANS IF PD DIAGNOSED ON BONE SCAN ONLY) CONSISTENT WITH PROGRESSIVE PROSTATE CANCER, AND/OR
C) RISING PSA DEFINED AS 2 SEQUENTIAL INCREASES ABOVE A PREVIOUS LOWEST REFERENCE VALUE. EACH VALUE MUST BE OBTAINED AT LEAST 1 WEEK APART. A PSA VALUE OF AT LEAST 2 NG/ML IS REQUIRED AT STUDY ENTRY.
104. EFFECTIVE CASTRATION (SERUM TESTOSTERONE LEVELS ≤ 0.50 NG/ML) BY ORCHIECTOMY AND/OR LHRH AGONISTS OR ANTAGONIST WITH OR WITHOUT ANTI-ANDROGENS.
A) IF THE PATIENT HAS BEEN TREATED WITH LHRH AGONISTS OR ANTAGONIST (I.E., WITHOUT ORCHIECTOMY), THEN THIS THERAPY SHOULD BE CONTINUED.
B) IF PATIENTS WERE EITHER STARTED ON COMPLETE ANDROGEN BLOCKADE, OR HAD A PSA RESPONSE (DEFINED BY ANY REDUCTION IN PSA SUSTAINED FOR AT LEAST 3 MONTHS) AFTER ADDING AN ANTIANDROGEN, PRIOR ANTI-ANDROGEN THERAPY SHOULD BE STOPPED BEFORE RANDOMIZATION: AT LEAST 6 WEEKS FOR BICALUTAMIDE AND NILUTAMIDE, AND AT LEAST 4 WEEKS FOR FLUTAMIDE, MEGESTROL ACETATE AND ANY OTHER HORMONAL THERAPY.
E 01. PRIOR CHEMOTHERAPY FOR PROSTATE CANCER, EXCEPT ESTRAMUSTINE AND EXCEPT ADJUVANT/NEOADJUVANT TREATMENT COMPLETED >3 YEARS AGO. PRIOR TREATMENT WITH SIPULEUCEL-T IMMUNOTHERAPY IS ALLOWED AT THE CONDITION PATIENT DID NOT RECEIVED PRIOR ANTICANCER THERAPY.
E 02. LESS THAN 28 DAYS ELAPSED FROM PRIOR TREATMENT WITH ESTRAMUSTINE, RADIOTHERAPY OR SURGERY TO THE TIME OF RANDOMIZATION. PATIENTS MAY BE ON BIPHOSPHONATES PRIOR TO STUDY ENTRY.
E 03. PRIOR ISOTOPE THERAPY, WHOLE PELVIC RADIOTHERAPY, OR RADIOTHERAPY TO >30% OF BONE MARROW (SEE APPENDIX F).
E 04. ADVERSE EVENTS (EXCLUDING ALOPECIA AND THOSE LISTED IN THE SPECIFIC EXCLUSION CRITERIA) FROM ANY PRIOR ANTICANCER THERAPY OF GRADE> 1 AT THE TIME OF RANDOMIZATION (NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA [NCI CTCAE] V4.03) (9).
E 05. LESS THAN 18 YEARS.
E 06. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS >2 (SEE APPENDIX C).
E 07. HISTORY OF BRAIN METASTASES, UNCONTROLLED SPINAL CORD COMPRESSION, OR CARCINOMATOUS MENINGITIS OR NEW EVIDENCE OF BRAIN OR LEPTOMENINGEAL DISEASE.
E 08. PRIOR MALIGNANCY. ADEQUATELY TREATED BASAL CELL OR SQUAMOUS CELL SKIN OR SUPERFICIAL (PTIS, PTA, AND PTL) BLADDER CANCER ARE ALLOWED, AS WELL AS ANY OTHER CANCER FOR WHICH CHEMOTHERAPY HAS BEEN COMPLETED >5 YEARS AGO AND FROM WHICH THE PATIENT HAS BEEN DISEASE-FREE FOR >5 YEARS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method