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

Primary Purpose

Metastatic Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metastatic Prostate Cancer focused on measuring prostate, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Institut Paoli Calmettes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metastatic prostate cancer blood samples

Arm Description

Outcomes

Primary Outcome Measures

Response time to castration
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

Secondary Outcome Measures

Level of alcaline phosphatase
Tumor volume

Full Information

First Posted
November 7, 2016
Last Updated
January 8, 2020
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT02963155
Brief Title
Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
Acronym
NKPROSTATE
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 7, 2018 (Actual)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
prostate, metastatic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metastatic prostate cancer blood samples
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
Response time to castration
Description
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)
Time Frame
every 6 months during 3 years-follow up
Title
Survival
Time Frame
every 6 months during 3 and 5 years-follow up
Secondary Outcome Measure Information:
Title
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
Title
Tumor volume
Time Frame
at diagnostic (before inclusion in the study)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with metastatic prostate cancer. Aged of 18 years or more. Patient in period of sensitivity to castration (patient non castrated or castration performed less than 1 year ago) and lack of progression. Patient having signed an informed consent. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen. Exclusion Criteria: Patient under chemotherapy treatment at the time of sampling Patient under corticotherapy treatment at the time of sampling Patient in emergency situation, adult subject to a measure of legal protection (placed under judicial protection, tutorship, or curatorship), or unable to give consent. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study medical follow-up Contraindications to study procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwenaelle GRAVIS, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25961317
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.
Results Reference
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PubMed Identifier
19552894
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.
Results Reference
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PubMed Identifier
21841316
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.
Results Reference
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Links:
URL
http://institutpaolicalmettes.fr
Description
official website of the sponsor

Learn more about this trial

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

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