Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary treatment with I-125 seeds or HDR-BT

No previous treatment for prostate cancer

Age ≥ 18 years

HDR- or PDR-BT

Disqualifiers

Pre-existent auto-immune disease

patients under bloodthinning medication

substance abuse

Trial population

Prostate cancer patients planning to undergo sole brachytherapy treatment

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Primary brachytherapy
Group B: Salvage brachytherapy

Trial outcomes

Primary outcomes

1

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.

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.

Secondary outcomes

1

Treatment-related toxicity

Acute toxicity related to brachytherapy

Time frame
Up to 6 months
2

recurrence-free survival

recurrence-free survival

Time frame
Up to 6 months
3

Overall survival

Overall survival

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Erlangen-Nürnberg Medical School

Lead sponsor

Bavarian Cancer Research Center (BZKF)

Collaborator

University Hospital Augsburg

Collaborator

Ludwig-Maximilians - University of Munich

Collaborator