metastatic Castrate Resistant Prostate Cancer (mCRPC).
Conditions
Sponsors
AB Science
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patient aged = 18 years old, with histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone 1 x LLN ? Proteinuria 6 months 6. Patient with BMI > 18 and patient weight > 40 kg 7. Man who agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for three months after the last treatment intake 8. Patient able and willing to comply with study procedures as per protocol 9. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent. 10. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: 1. Patient who has been previously treated with chemotherapy. 2. Patient with bone marrow irradiation > 40% within 12 months before baseline 3. Patient treated for a cancer other than prostate cancer within 3 years before enrollment, with the exception of basal cell carcinoma (and pTa or pT1) 4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: ? Patient with recent cardiac history (within 6 months) of: o Acute coronary syndrome o Acute heart failure (class III or IV of the NYHA classification) o Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) ? Patient with cardiac failure class III or IV of the NYHA classification ? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) ? Syncope without known aetiology within 3 months ? Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension 6. Patient with an history of poor compliance or an history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 7. Patient under treatment with any anti-tumour therapy (any radiotherapy, chemotherapy, biologic or anti-androgen therapy except GnRH/LHRH analogs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall survival (OS);Secondary Objective: Secondary endpoint ? Survival rate every 6 months ? Overall Progression Free Survival (PFS) ? PFS rate every 12 weeks ? Overall Time To Progression (TTP) ? TTP rate every 12 weeks ? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks ? Decline of PSA level ? 30% from baseline at time point ? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ) o Analgesic intake o ECOG Performance Status o Pain improvement (VAS) ? Pharmacogenomic assessment: Relationship between genomic data and overall survival. ? Safety profile using the NCI CTCAE v4.03 classification;Primary end point(s): ? Overall Survival (OS) is defined as the time from the randomization to the date of documented death;Timepoint(s) of evaluation of this end point: Date of documented death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Survival rate every 6 months ? Overall Progression Free Survival (PFS) ? PFS rate every 12 weeks ? Overall Time To Progression (TTP) ? TTP rate every 12 weeks ? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks ? Decline of PSA level ? 30% from baseline at time point ? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ) o Analgesic intake o ECOG Performance Status o Pain improvement (VAS) ? Pharmacogenomic assessment: Relationship between genomic data and overall survival. ? Safety profile using the NCI CTCAE v4.03 classification;Timepoint(s) of evaluation of this end point: Every 12 weeks | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, China, Czech Republic, Greece, Hong Kong, Hungary, India, Italy, Korea, Republic of, Malaysia, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Tunisia, Ukraine, United Kingdom, United States
Contacts
Public ContactBeatrice Martin
AB Science
Outcome results
None listed