Metastatic Prostate CancerNKPROSTATENCT02963155
Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
A study testing Blood samples in people with Metastatic Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2016to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.
Read the 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.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Blood samples
- Keywords
- prostate, metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Metastatic prostate cancer blood samples | Experimental | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: every 6 months during 3 years-follow up
Survival
Measured: every 6 months during 3 and 5 years-follow up
Secondary outcomes (2)
Level of alcaline phosphatase
Measured: at diagnostic (before inclusion in the study) and at time of treatment for progression in the course of 3 years-follow-up
Tumor volume
Measured: at diagnostic (before inclusion in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start15 Nov 2016
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenaelle GRAVIS, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963155
- Sponsor's protocol ID
- NKPROSTATE-IPC 2015-019
- Acronym
- NKPROSTATE
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2016
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25961317Gannon 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.
PubMed 19552894Mamessier 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.
PubMed 21841316
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
- ClinicalTrials.gov ID
- NCT02963155
- Acronym / sponsor ID
- NKPROSTATE / NKPROSTATE-IPC 2015-019
- Conditions
- Metastatic Prostate Cancer
- Keywords
- prostate, metastatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic prostate cancer blood samples | Experimental | Other: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples | Other | Metastatic prostate cancer blood samples |
Primary outcome
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
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 25961317Pasero 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.
- Background: PubMed 19552894Gannon 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.
- Background: PubMed 21841316Mamessier 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.
- official website of the sponsorLink provided by the sponsor.
Related trials for Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenaelle GRAVIS, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Metastatic Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time to castration (time frame: every 6 months during 3 years-follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963155, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.