Prostate CancerPRIMUSNCT04247217
Immune Profiling After HDR in Local Relapsed Prostate Cancer
An observational study of Prostate Cancer and PD-L1, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, PD-L1
- What is being tested?
- HDR salvage brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Feb 2020to 23 Dec 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with local relapse of prostate cancer, who are candidate for a salvage HDR treatment will be asked to participate in this study at the time of intake.
Who may be able to join
- Local relapse of prostate cancer, who is candidate for a salvage HDR treatment:
- Biochemical relapse (PSA increase)
- Local relapse on imaging: PSMA scan, mp-MRI
- Pathology proven relapse
- Willing and able to comply with the study prescriptions.
- 18 years or older
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Who cannot join
- Not eligible for proposed (HDR brachytherapy) treatment:
- Life expectancy < 10 years
- Distant Metastasis
- Recently TURP with big urethral defect
- Not able to stop anticoagulants
- Flow < 10 ml/sec • No compliance to study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostate Cancer Immune Profiling Before, During and After HDR-brachytherapy in Local Relapsed Prostate Cancer (PRIMUS-study)
Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic T cells. RT-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or T-cell attracting chemokines and by increasing T-cell docking molecules on the endothelial cells like VCAM-1. The main-hypothesis is that HDR-brachytherapy will turn an immunologically "cold" (no T-cell infiltrations) prostate cancer into an immunologically "hot" (CD4 and CD8-cell infiltrations) tumor, creating leverage points for different forms of IO.
Read the detailed description
Prospective analysis of biopsies from 10 patients with local recurrence in the prostate selected for salvage HDR brachytherapy in MAASTRO Clinic, Maastricht. HDR treatment is standard in Maastro Clinic for local relapses of prostate cancer after previously irradiation (internal or external).
Biopsies will be taken at 4 different time points (before and after the 1st fraction; before the 2nd and 3rd fraction of the salvage treatment).
Several immunotyping (expression of PD-(L)-1, CXCL12, IL-23 receptor, etc.) and HLA class I expression will be performed on the biopsies. In addition, HLA genotypes will be determined on DNA isolated from pheripheral blood.
The plasma and the biopsies will be stored for eventually additional research.
- Conditions
- Prostate Cancer, PD-L1
- Being tested
- HDR salvage brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR salvage brachytherapyRadiation
Also called biopsies
In patients receiving HDR salvage brachytherapy for locally relapsed prostate cancer serial biopsies will be performed at 4 different time points.
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of PD-(L)-1 receptor
Expression of PD-(L)-1 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points.
Measured: up to 28 days
Secondary outcomes (7)
Expression patterns of CXCL12
Expression of CXCL12 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Expression patterns of IL-23
Expression of IL-23 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Expression patterns of MDSC
Expression of MDSC receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Changes in T cell infiltration profiles
Changes in T cell infiltration profiles induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Changes in HLA class I-A expression on tumor cells
Changes in HLA class I-A expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Changes in HLA class I-B expression on tumor cells
Changes in HLA class I-B expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Changes in HLA class I-C expression on tumor cells
Changes in HLA class I-C expression on tumor cells induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start19 Feb 2020
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben Vanneste, MD, PhD, Principal investigator, Maastro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247217
- Sponsor's protocol ID
- PRIMUS
- Acronym
- PRIMUS
- Status last verified
- May 2022
- First submitted
- 17 Jan 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Immune Profiling Before, During and After HDR-brachytherapy in Local Relapsed Prostate Cancer (PRIMUS-study)
- ClinicalTrials.gov ID
- NCT04247217
- Acronym / sponsor ID
- PRIMUS / PRIMUS
- Conditions
- Prostate Cancer, PD-L1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- 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.
Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer until now fails to respond to classical IO, like PD-1 and CTLA-4 inhibitors. Radiotherapy (RT) delivered to the primary tumor impacts both tumor cells and surrounding stromal cells. Radiation damage to cancer cells exposes tumor-specific antigens leading to increased visibility to the immune system by improved priming and activation of cytotoxic T cells. RT-induced modulation of the tumor microenvironment may also facilitate the recruitment and infiltration of immune cells by increasing the expression or T-cell attracting chemokines and by increasing T-cell docking molecules on the endothelial cells like VCAM-1. The main-hypothesis is that HDR-brachytherapy will turn an immunologically "cold" (no T-cell infiltrations) prostate cancer into an immunologically "hot" (CD4 and CD8-cell infiltrations) tumor, creating leverage points for different forms of IO.
Detailed description
Prospective analysis of biopsies from 10 patients with local recurrence in the prostate selected for salvage HDR brachytherapy in MAASTRO Clinic, Maastricht. HDR treatment is standard in Maastro Clinic for local relapses of prostate cancer after previously irradiation (internal or external).
Biopsies will be taken at 4 different time points (before and after the 1st fraction; before the 2nd and 3rd fraction of the salvage treatment).
Several immunotyping (expression of PD-(L)-1, CXCL12, IL-23 receptor, etc.) and HLA class I expression will be performed on the biopsies. In addition, HLA genotypes will be determined on DNA isolated from pheripheral blood.
The plasma and the biopsies will be stored for eventually additional research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients with local relapse of prostate cancer, who are candidate for a salvage HDR treatment will be asked to participate in this study at the time of intake.
Key inclusion criteria (7 listed)
- Local relapse of prostate cancer, who is candidate for a salvage HDR treatment:
- Biochemical relapse (PSA increase)
- Local relapse on imaging: PSMA scan, mp-MRI
- Pathology proven relapse
Key exclusion criteria (6 listed)
- Not eligible for proposed (HDR brachytherapy) treatment:
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 |
|---|---|---|
| HDR salvage brachytherapyAlso: biopsiesIn patients receiving HDR salvage brachytherapy for locally relapsed prostate cancer serial biopsies will be performed at 4 different time points. | Radiation | – |
Primary outcome
Expression of PD-(L)-1 receptor
Time frame: up to 28 days
Expression of PD-(L)-1 receptor induced by HDR-brachytherapy in prostate tumor biopsies of local relapses of prostate cancer of 10 patients at 4 different time points.
7 secondary outcomes
Expression patterns of CXCL12
Time frame: up to 28 days
Expression patterns of IL-23
Time frame: up to 28 days
Expression patterns of MDSC
Time frame: up to 28 days
Changes in T cell infiltration profiles
Time frame: up to 28 days
Changes in HLA class I-A expression on tumor cells
Time frame: up to 28 days
Changes in HLA class I-B expression on tumor cells
Time frame: up to 28 days
Changes in HLA class I-C expression on tumor cells
Time frame: up to 28 days
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 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Ben Vanneste, MD, PhD principal investigator
Maastro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and PD-L1, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 7 inclusion and 6 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 26 May 2022. 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 Netherlands. 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?
Expression of PD-(L)-1 receptor (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2022.