Lab Research Using Mini-tumors to Study Prostate Cancer Treatments

NCT07004582 | Recruiting

• 2 other identifiers: PR3DICTNL-009852
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Prostate Cancer Metastatic Disease; Prostate Cancer Recurrent; Advanced Prostate Cancer; Prostate Cancer

Keywords

Advanced prostate cancer; Metastatic prostate cancer; Prostate cancer; Patient-tailored treatment; Precision Medicine; Ex vivo prediction platform; Personalized medicine; Drug Screening Assays; Three-Dimensional Culture Techniques; Organoids; Tumoroids; Tumor replicas; Prostatic Neoplasms; Neoplasm Metastasis; Advanced Cancer; Treatment Outcome; Human Tissue Culture Techniques

Outcome Measures

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).

  1 year

Secondary Outcomes (3)

• Most successful culturing technique per subtype

  1 year

• (epi)genetic and phenotypic tumor features

  1 year

• Treatment response

  5 years

Study Arms (2)

HDR brachytherapy

High-risk or recurrent prostate cancer patients that will undergo high dose rate (HDR) brachytherapy.

Procedure: HDR brachytherapy

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 Test: Diagnostic biopsy

Interventions

Diagnostic biopsy DIAGNOSTIC_TEST

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

Diagnostic biopsy

HDR brachytherapy PROCEDURE

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

HDR brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Zuyderland Medical Centre: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (3)

Zuyderland Medisch Centrum

Heerlen, Limburg, 6419 PC, Netherlands

NOT YET RECRUITING

Academisch Ziekenhuis Maastricht

Maastricht, Limburg, 6229 ET, Netherlands

NOT YET RECRUITING

Maastricht Radiation Oncology

Maastricht, Limburg, 6229 ET, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Prostate cancer tissue and blood samples

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evert J Van Limbergen, PhD, MD

  Maastricht Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris EWG Laven, PhD

CONTACT

0031(0)884455666; iris.laven@maastro.nl

Chantal Overhof, BEc

CONTACT

0031(0)884455666; groepcto@maastro.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 4, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)