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

Not Applicable

• Conditions: Metastatic Prostate Cancer
• Interventions: Other: Blood samples

• Registration Number: NCT02963155
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-15
• Primary Completion: 2018-07-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic prostate cancer blood samples	Blood samples	-

Primary Outcome Measures

Name	Time	Method
Response time to castration	every 6 months during 3 years-follow up	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)
Survival	every 6 months during 3 and 5 years-follow up

Secondary Outcome Measures

Name	Time	Method
Tumor volume	at diagnostic (before inclusion in the study)
Level of alcaline phosphatase	at diagnostic (before inclusion in the study) and at time of treatment for progression in the course of 3 years-follow-up

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, France