Lab Research Using Mini-tumors to Study Prostate Cancer Treatments

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorMaastricht Radiation Oncology

About this trial

For men with an aggressive form of prostate cancer, finding the right and effective treatment right away is challenging. Many of these men face a high risk of cancer recurrence: about half experience a relapse after surgery, and more than a third after undergoing radiation therapy. Men with metastatic prostate cancer have particularly poor prognoses, with a five-year survival rate of only 30% to 50%. In short, it is difficult to predict which treatment, or combination of treatments, will lead to longer survival for this group of men with aggressive (metastatic) prostate cancer.

In the laboratory, it is possible to grow small samples of tumors into 3D mini-tumors. These mini-tumors retain the characteristics of the patient's original tumor tissue. Various treatments can be tested on these 3D mini-tumors to determine which therapy is most effective for each individual case. There are currently two techniques available for creating these 3D mini-tumors in the lab. In this project, we aim to investigate which of these two techniques works best in order to test and personalize treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older

Patients with prostate cancer

Patients planned for HDR brachytherapy treatment for high-risk or recurrent prostate cancer or transperineal prostate biopsy with MRI-suspected metastatic prostate cancer with at least clinical stage T3-4.

Disqualifiers

Patients younger than 18 years

Patients of whom it is not possible to obtain left-over tissue as part of the normal clinical treatment procedure (e.g., if all tumor material is required for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis).

Trial population

Patients planned for HDR brachytherapy treatment for high-risk or recurrent prostate cancer or transperineal prostate biopsy with MRI-suspected metastatic prostate cancer with at least clinical stage T3-4.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • HDR brachytherapy

    Procedure/Surgery

    High dose rate (HDR) brachytherapy for the treatment of high-risk or recurrent prostate cancer

  • Diagnostic biopsy

    Diagnostic test

    Transperineal prostate biopsies guided with transrectal ultrasound for the diagnosis of (recurrent) prostate cancer

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: HDR brachytherapy1 intervention
Group B: Diagnostic biopsy1 intervention

Trial outcomes

Primary outcomes

1

Success rate

Determine the success rate of the established ex vivo prostate cancer 3D cultures from patient-derived (tumor) tissue material in which at least one first-line or second-line prostate cancer treatment (encompassing radiation exposure or cancer drugs) has been tested for sensitivity within a clinically relevant timeframe (up to 2 months).

Time frame
1 year

Secondary outcomes

1

Most successful culturing technique per subtype

Evaluate the most successful culturing technique (organoid versus tumor replica) per prostate cancer subtype (e.g., different morphologies such as adenocarcinoma, carcinoid or neuroendocrine features; various tumor stages) for generating ex vivo patient-derived prostate cancer 3D cultures from biopsy tissue along with subsequent testing of first-line, second-line or novel/personalized prostate cancer treatments.

Time frame
1 year
2

(epi)genetic and phenotypic tumor features

To investigate the stability of (epi-) genetic and phenotypic tumor features of patient-derived 3D prostate cancer cultures compared to the tumor of origin using, for example, H\&E staining or immunohistochemistry stainings.

Time frame
1 year
3

Treatment response

Compare the preclinical ex vivo patient-derived prostate cancer 3D culture predicted treatment sensitivity to prostate cancer drugs and/or radiation therapy to the patient clinical response, if possible.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Maastricht Radiation Oncology

Lead sponsor

Zuyderland Medical Centre

Collaborator

Maastricht University Medical Center

Collaborator