Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration (NKPROSTATE)

Institut Paoli-Calmettes

Status: Unknown

Conditions: Metastatic Prostate Cancer

Treatments: Other: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02963155

NKPROSTATE-IPC 2015-019

Details and patient eligibility

About

Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.

Full description

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with metastatic prostate cancer.
2. Aged of 18 years or more.
3. Patient in period of sensitivity to castration (patient non castrated or castration performed less than 1 year ago) and lack of progression.
4. Patient having signed an informed consent.
5. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.

Exclusion criteria

1. Patient under chemotherapy treatment at the time of sampling
2. Patient under corticotherapy treatment at the time of sampling
3. Patient in emergency situation, adult subject to a measure of legal protection (placed under judicial protection, tutorship, or curatorship), or unable to give consent.
4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study medical follow-up
5. Contraindications to study procedure

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Metastatic prostate cancer blood samples

Experimental group

Treatment:

Other: Blood samples