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

Overview

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

Full Title of Study: “Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 7, 2018

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.

Interventions

  • Other: Blood samples

Arms, Groups and Cohorts

  • Experimental: Metastatic prostate cancer blood samples

Clinical Trial Outcome Measures

Primary Measures

  • Response time to castration
    • Time Frame: 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
    • Time Frame: every 6 months during 3 and 5 years-follow up

Secondary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut Paoli-Calmettes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gwenaelle GRAVIS, MD, Principal Investigator, Institut Paoli-Calmettes

References

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.

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.

Mamessier E, Sylvain A, Thibult ML, Houvenaeghel G, Jacquemier J, Castellano R, Gonçalves A, André P, Romagné 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.

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