Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

AB Science714 enrolled

Overview

Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.

The objective of this study is to evaluate the efficacy and safety of masitinib in combination with docetaxel and prednisone with respect to placebo in combination with docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

714

Conditions

Metastatic Castrate Resistant Prostate Cancer

Interventions

MasitinibDRUG

DocetaxelDRUG

PrednisoneDRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 \< 0.5ng/ml) with one of the following criteria: * Pre-treated with abiraterone with documented progressive disease, OR * Indicated for initiating docetaxel treatment (e.g., widespread visceral disease or rapidly progressive disease). 2. Patient with evidence of progressive metastatic disease as assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations. 3. Patient with adequate organ function as per protocol Exclusion Criteria: 1\. Patient who has been previously treated with chemotherapy.

Locations (9)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Canada

Polyclinique d'oncologie de Gentilly

Nancy, France

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, India

Centro di Riferimento Oncologico

Aviano, Italy

Outcomes

Primary Outcomes

Progression Free Survival

Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.

Time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months

Secondary Outcomes

Overall Survival

Overall survival (OS) is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.

Time frame: From day of randomization to death, assessed for a maximum of 60 months

Data from ClinicalTrials.gov

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