Metastatic castration-resistant prostate carcinoma men, aged >/= 18 years MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Abiraterone acetate (Zytiga®)
Product Name: Abiraterone acetate (Zytiga®)
Pharmaceutical Form: Tablet
INN or Proposed INN: acétate d'abiratérone
Other descriptive name: abiraterone aceta
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Step 1 - Male 18 years and older. - Voluntary signed informed consents of the patient - Histologically confirmed prostate adenocarcinoma. - Presence of bone and/or soft-tissue and/or visceral metastases through CT scan, MRI, or scintigraphy scan. - Progressive disease assessed by PSA, CT scan, MRI or bone scan according to the PCGW3 criteria - Patient with no or moderate symptoms (no need for continuous opioid treatment) - Effective castration confirmed by testosterone plasma level 3 months - Patient affiliate to french social secutity - Laboratory criteria: SGPT and SGOT 3 mM Step 2 - Patients receiving ABI 1000 mg/day through step 1 for at least two months - At least two measures of ABI plasma concentrations available within the first three months of treatment - Mean of ABI concentration =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Step 1 - Pure small cell carcinoma of the prostate or predominant histology of neuro-endocrine carcinoma - Confirmed brain and/or leptomeningeal metastases - Previous treatment with docetaxel or any other anticancer treatment for castration-resistant prostate carcinoma (previous docetaxel for hormone-sensitive metastatic disease is allowed) - Previous treatment with ABI or any other 17 B hydroxylase inhibitor or Enzalutamide -Treatment with first-generation antiandrogen performed on the day of screening or within previous four weeks. - Patient co-morbidities: Galactose hypersensitivity, Lapp lactase deficiency. Cirrhosis Child-Pugh B or C Active or symptomatic viral hepatitis Heart failure stage NYHA III or IV Cardiac arythmia, heart failure stage NYHA II, ischemic cardiopathy or uncontroled hypertension, except if left ventricular ejection fraction is > 50% Patients with left ventricular ejection fraction (LVEF) < 50% Severe hypokaliema Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications. Prior or concurrent malignant disease in complete remission for less than 3 years, except T1N0 vocal cord carcinoma, basal or squamous cell skin carcinoma and in situ transitional cell bladder carcinoma - Limitation of the patient's ability to comply with the treatment or to follow the protocol. Step 2 - Persistent grade 3-4 toxicities related to ABI. In case of persistent grade 2 toxicity or resolutive grade 3-4 toxicities, inclusion in step 2 must be discussed in a case by case basis with the study coordinating Investigator. - All non-inclusion criteria for step 1 apply - Patient who does not take ABI daily at the investigator opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Non-progression rate at 12 weeks in patients receiving ABI at a dose of 2000 mg / day after failure of standard dose (1000 mg/day).;Secondary Objective: Step 1: - Incidence of underexposure to ABI during the first three months in patients treated at standard dose (1000 mg/day) and identification of inter- and intra-individual variability factors of plasma levels of ABI. - Evaluation of medical adherence and correlation with mean ABI concentration and socioeconomic conditions. - Progression free survival (time from the day of inclusion to disease progression or death) and correlation with underexposure to ABI. Step 2: - PSA response rate. - Progression free survival. - Safety of ABI at a dose of 2000 mg/day. ;Primary end point(s): The primary endpoint is the proportion of patients who do not experience progressive disease at 12 weeks from the day of inclusion in step 2. At 12 weeks, disease progression will be defined by PSA and/or radiographic progression. Secondary endpoints are : - Underexposure to ABI - Measure of medical adherence - PSA response rate - Progression-free survival - Safety of dose escalation;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Underexposure to ABI Measure of medical adherence PSA response rate Progression-free survival Safety of dose escalation;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed