Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.
The main objective is to validate prospectively the results of a retrospective study showing a correlation between the level of NKp30 and NKp46 receptor-activators expression on the surface of NK cells and 1) the survival time, 2) the response time to castration in patients with metastatic prostate cancer. Prospective monocenter, open-label study. During a visit in the frame of management of the disease, a single blood sample will be collected. Patients will then have a standard care follow-up for a period of 5 years. Follow up data (death, progression) will be collected every 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Institut Paoli Calmettes
Marseille, France
Response time to castration
Time of occurrence of: * confirmed PSA rise + serum testosterone \< 0.50 ng/mL * and/or radiological progression according to the modified PCWG2 criteria (progression according to the RECIST criteria v1.1 or documented by the appearance of at least 2 new lesions on the bone scan)
Time frame: every 6 months during 3 years-follow up
Survival
Time frame: every 6 months during 3 and 5 years-follow up
Level of alcaline phosphatase
Time frame: at diagnostic (before inclusion in the study) and at time of treatment for progression in the course of 3 years-follow-up
Tumor volume
Time frame: at diagnostic (before inclusion in the study)
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