Lab Research Using Mini-tumors to Study Prostate Cancer Treatments
NCT ID: NCT07004582
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2026-02-10
2031-12-30
Brief Summary
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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.
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Detailed Description
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Ex vivo patient-derived 3D cultures may be an excellent solution which is able to recapitulate histological characteristics of the original tumor and could be utilized to assess tumorigenesis, potential drug targets and patients' drug responsiveness. Aside from the preservation of histological characteristics of the original tumor, ex vivo patient-derived 3D cultures are able to maintain physiological tumor features by preservation of the tumor micro-environment which is essential for testing selected types of anti-cancer drugs. Ex vivo patient-derived 3D cultures are generated from small fragments of tumor tissue containing organ-specific (tumor) cell types, which are cultivated into miniature, self-organizing prostate tumors using one of two principal techniques: organoid (i.e., utilizing a basement membrane exact) or tumor replica technology (i.e., utilizing a suspension culture without matrix support). Success rates of culturing prostate cancer organoids based on left-over tissue after radical prostatectomy are excellent, varying between 90% and 98%, however, for the more high-risk (metastasized) prostate cancers, the success rates vary considerably from 16% to 44% based on the small amount of needle biopsy tissue and inherent low cellular yield, limited cell-cell interaction, or prostate cancer subtype specific growth factors.
To overcome the above-mentioned low success-rates, the high turnaround time, and challenges of deriving (metastasized) prostate cancer organoids, the tumor replica technology may be interesting to explore. The tumor replica technology is optimized by Rianne Vaes at the Maastro Lab in the IPON-3 study for lung cancer (NL79010.068.21) and has increased the success rate from 17% to 70% (unpublished). So far, only one study generated prostate cancer tumor replicas utilizing this technique and showed an excellent success rate of 100% after radical prostatectomy. However, the establishment and use of tumor replicas derived from high-risk (metastatic) prostate cancer biopsies have been described yet, nor have been from prostate cancer recurrence following initial radiation therapy (i.e. radioresistant prostate cancer). Moreover, only one study demonstrated the capability of predicting the therapy response for prostate cancer drugs as well as radiation therapy on patient-derived 3D organoids of treatment-naïve prostate cancer patients utilizing left-over prostatectomy tissue. The number of patients on which treatment responsiveness was tested, however, was low (3 patients tested for prostate cancer drugs and 2 for radiation therapy).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HDR brachytherapy
High-risk or recurrent prostate cancer patients that will undergo high dose rate (HDR) brachytherapy.
HDR brachytherapy
High dose rate (HDR) brachytherapy for the treatment of high-risk or recurrent prostate cancer
Diagnostic biopsy
Patients with MRI-suspected metastatic prostate cancer - with at least clinical stage T3-4 disease - that will undergo a diagnostic transperineal prostate biopsy procedure guided with ultrasound (i.e., targeted or template prostate cancer needle biopsies taken through the perineum guided with transrectal ultrasound)
Diagnostic biopsy
Transperineal prostate biopsies guided with transrectal ultrasound for the diagnosis of (recurrent) prostate cancer
Interventions
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HDR brachytherapy
High dose rate (HDR) brachytherapy for the treatment of high-risk or recurrent prostate cancer
Diagnostic biopsy
Transperineal prostate biopsies guided with transrectal ultrasound for the diagnosis of (recurrent) prostate cancer
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
MALE
No
Sponsors
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Zuyderland Medical Centre
OTHER
Maastricht University Medical Center
OTHER
Maastricht Radiation Oncology
OTHER
Responsible Party
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Principal Investigators
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Evert J Van Limbergen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht Radiation Oncology
Locations
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Zuyderland Medisch Centrum
Heerlen, Limburg, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, Netherlands
Maastricht Radiation Oncology
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL-009852
Identifier Type: REGISTRY
Identifier Source: secondary_id
PR3DICT
Identifier Type: -
Identifier Source: org_study_id
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