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

NCT ID: NCT02963155

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Metastatic Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metastatic prostate cancer blood samples

Group Type EXPERIMENTAL

Blood samples

Intervention Type OTHER

Interventions

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Blood samples

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gwenaelle GRAVIS, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli Calmettes

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 25961317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19552894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21841316 (View on PubMed)

Related Links

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http://institutpaolicalmettes.fr

official website of the sponsor

Other Identifiers

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NKPROSTATE-IPC 2015-019

Identifier Type: -

Identifier Source: org_study_id

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