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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
HDR brachytherapy
Procedure/SurgeryHigh dose rate (HDR) brachytherapy for the treatment of high-risk or recurrent prostate cancer
Diagnostic biopsy
Diagnostic testTransperineal prostate biopsies guided with transrectal ultrasound for the diagnosis of (recurrent) prostate cancer
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
(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.
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.
Sponsors and contacts
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Maastricht Radiation Oncology
Lead sponsor
Zuyderland Medical Centre
Collaborator
Maastricht University Medical Center
Collaborator