Metastatic Castrate Resistant Prostate Cancer
Conditions
Keywords
metastatic castration-resistant prostate cancer, metastatic hormone-resistant prostate cancer, tyrosine kinase inhibitor, mCRPC, mHRPC
Brief summary
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.
Detailed description
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.
Interventions
DRUGMasitinib
DRUGDocetaxel
DRUGPrednisone
DRUGPlacebo
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | From day of randomization to disease progression or death, assessed for a maximum of 60 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From day of randomization to death, assessed for a maximum of 60 months | 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. |
Countries
Canada, France, India, Italy, Malaysia, Russia
Outcome results
None listed