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

Metastatic Prostate Cancer Clinical Trial

— NKPROSTATE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02963155
• Other study ID #: NKPROSTATE-IPC 2015-019
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2021

Study information

• Verified date: January 2020
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2021
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Blood samples

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Survival		every 6 months during 3 and 5 years-follow up
Secondary	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
Secondary	Tumor volume		at diagnostic (before inclusion in the study)

External Links

•   official website of the sponsor