Clinical trial NCT02963155: Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
Official title: Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Prostate Cancer
Keywords: prostate, metastatic
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response time to castration
timeFrame: every 6 months during 3 years-follow up
measure: Survival
timeFrame: every 6 months during 3 and 5 years-follow up
Secondary outcomes:
measure: Level of alcaline phosphatase
timeFrame: at diagnostic (before inclusion in the study) and at time of treatment for progression in the course of 3 years-follow-up
measure: Tumor volume
timeFrame: at diagnostic (before inclusion in the study)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Gwenaelle GRAVIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasero C, Gravis G, Granjeaud S, Guerin M, Thomassin-Piana J, Rocchi P, Salem N, Walz J, Moretta A, Olive D. Highly effective NK cells are associated with good prognosis in patients with metastatic prostate cancer. Oncotarget. 2015 Jun 10;6(16):14360-73. doi: 10.18632/oncotarget.3965.
citation: Gannon PO, Poisson AO, Delvoye N, Lapointe R, Mes-Masson AM, Saad F. Characterization of the intra-prostatic immune cell infiltration in androgen-deprived prostate cancer patients. J Immunol Methods. 2009 Aug 31;348(1-2):9-17. doi: 10.1016/j.jim.2009.06.004. Epub 2009 Jun 22.
citation: Mamessier E, Sylvain A, Thibult ML, Houvenaeghel G, Jacquemier J, Castellano R, Goncalves A, Andre P, Romagne F, Thibault G, Viens P, Birnbaum D, Bertucci F, Moretta A, Olive D. Human breast cancer cells enhance self tolerance by promoting evasion from NK cell antitumor immunity. J Clin Invest. 2011 Sep;121(9):3609-22. doi: 10.1172/JCI45816. Epub 2011 Aug 15.