Prostate Cancer (Diagnosis)NCT07131956
Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy
An observational study of Prostate Cancer (Diagnosis) and Prostate Cancer Patients Who Have Brachytherapy Seed Implant, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
Trial summary
Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy
- How many people
- 200 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2025to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Prostate cancer patients planning to undergo sole brachytherapy treatment
Who may be able to join
- Primary treatment with I-125 seeds or HDR-BT
- No previous treatment for prostate cancer
- Age ≥ 18 years
- HDR- or PDR-BT
- No radiation therapy within three months before salvage treatment
- Complete documentation available on previous treatment for prostate cancer
- No history of prostatectomy
- Age ≥ 18 years
Who cannot join
- Pre-existent auto-immune disease
- patients under bloodthinning medication
- substance abuse
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna-Jasmina Donaubauer, Dr. rer. nat. contact
Germany3 sites, 3 recruiting
- Not yet recruiting
Klinik für Strahlentherapie
Augsburg, Bavaria, 86156
Klinik für Strahlentherapie Augsburg, +49 821 400-2080, strahlenklinik@uk-augsburg.de
- Recruiting
Strahlenklinik Erlangen
Erlangen, Bavaria, 91054
Strahlenklinik Erlangen Ambulanz, +4991318534080, sekretariat.strahlenklinik@uk-erlangen.de
- Not yet recruiting
Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Munich, Bavaria, 81377
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, +49 (0)89 / 4400 - 73770, strahl.onlinetermine@med.uni-muenchen.de
About this study
Official title: Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)
Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.
- Conditions
- Prostate Cancer (Diagnosis), Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Recurrent
- Keywords
- Immune-profiling in prostate cancer patients, brachytherapy for prostate cancer, interstitial brachytherapy for prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary brachytherapy | Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer | |
| Salvage brachytherapy | Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy
Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy in the primary as well as in the recurrent setting.
Measured: Blood withdrawal pre-brachytherapy treatment, during surgery, one day after brachytherapy and at the first follow-up visit 4-12 weeks later. Tissue samples at every brachytherapy procedure.
Secondary outcomes (3)
Treatment-related toxicity
Acute toxicity related to brachytherapy
Measured: Up to 6 months
recurrence-free survival
recurrence-free survival
Measured: Up to 6 months
Overall survival
Overall survival
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study startDec 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian Cancer Research Center (BZKF), University Hospital Augsburg, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Claudia Schweizer, University of Erlangen-Nürnberg Medical School
- Investigators
- Claudia Schweizer, MD, Principal investigator, Strahlenklinik Universitätsklinikum ErlangenAnna-Jasmina Donaubauer, Dr. rer. nat., Principal investigator, Strahlenklinik Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131956
- Sponsor's protocol ID
- ImmunBioProBrachy
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)
- ClinicalTrials.gov ID
- NCT07131956
- Acronym / sponsor ID
- ImmunBioProBrachy
- Conditions
- Prostate Cancer (Diagnosis), Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Recurrent
- Keywords
- Immune-profiling in prostate cancer patients, brachytherapy for prostate cancer, interstitial brachytherapy for prostate cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Bavarian Cancer Research Center (BZKF), University Hospital Augsburg, Ludwig-Maximilians - University of Munich
- Study start
- Dec 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Aug 2025 (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.
Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary brachytherapy | – | –Patients receiving sole primary brachytherapy (either LDR-BT or HDR-BT) for low or low intermediate risk prostate cancer |
| Salvage brachytherapy | – | –Patients receiving sole brachytherapy (either PDR-BT or HDR-BT) for locally recurrent prostate cancer after prior irradiation with prostate in situ |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients planning to undergo sole brachytherapy treatment
Key inclusion criteria (8 listed)
- Primary treatment with I-125 seeds or HDR-BT
- No previous treatment for prostate cancer
- Age ≥ 18 years
- HDR- or PDR-BT
- No radiation therapy within three months before salvage treatment
Key exclusion criteria (3 listed)
- Pre-existent auto-immune disease
- patients under bloodthinning medication
- substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy
Time frame: Blood withdrawal pre-brachytherapy treatment, during surgery, one day after brachytherapy and at the first follow-up visit 4-12 weeks later. Tissue samples at every brachytherapy procedure.
Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy in the primary as well as in the recurrent setting.
3 secondary outcomes
Treatment-related toxicity
Time frame: Up to 6 months
recurrence-free survival
Time frame: Up to 6 months
Overall survival
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- 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.
Anna-Jasmina Donaubauer, Dr. rer. nat. contact
Claudia Schweizer, MD principal investigator
Strahlenklinik Universitätsklinikum Erlangen
Anna-Jasmina Donaubauer, Dr. rer. nat. principal investigator
Strahlenklinik Universitätsklinikum Erlangen
3 sites 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 (Diagnosis) and Prostate Cancer Patients Who Have Brachytherapy Seed Implant, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Schweizer, MD (+49 9131 85 33968, claudia.schweizer@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal changes of peripheral immune cells and cell-free DNA and tumor-associated tissue in patients with prostate cancer treated with brachytherapy (time frame: Blood withdrawal pre-brachytherapy treatment, during surgery, one day after brachytherapy and at the first follow-up visit 4-12 weeks later. Tissue samples at every brachytherapy procedure.). 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 18 Nov 2025.