NCT02963155

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

November 7, 2016

Last Update Submit

January 8, 2020

Conditions

Metastatic Prostate Cancer

Keywords

prostate, metastatic

Outcome Measures

Primary Outcomes (2)

  • 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)

    every 6 months during 3 years-follow up

  • Survival

    every 6 months during 3 and 5 years-follow up

Secondary Outcomes (2)

  • 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

  • Tumor volume

    at diagnostic (before inclusion in the study)

Study Arms (1)

Metastatic prostate cancer blood samples

EXPERIMENTAL
Other: Blood samples

Interventions

Blood samplesOTHER
Metastatic prostate cancer blood samples

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Publications (3)

  • 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.

    PMID: 25961317BACKGROUND

  • 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.

    PMID: 19552894BACKGROUND

  • 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.

    PMID: 21841316BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gwenaelle GRAVIS, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

July 7, 2018

Study Completion

November 1, 2021

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

FR(1)