Prostate cancer
Conditions
Interventions
Preclinical ex vivo patient-derived prostate cancer 3D Cultures
Sponsors
Maastro
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with prostate cancer are eligible if they are candidate 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
Exclusion criteria: Patients younger than 18 years and 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is designed as an exploratory proof-of-concept study to evaluate the success rate of successfully established ex vivo 3D prostate cancer cultures. Given its exploratory nature, a one-sided 90%-confidence interval (a = 10%) is deemed appropriate. As mentioned before, we aim to achieve a success rate of 40%, with the lower bound of the confidence interval not falling below 33.4% (margin of 6.6%), which requires a minimal sample size of 100 prostate cancer patients. The establishment of successfully cultured ex vivo patient-derived prostate cancer 3D models will be carefully monitored in a logbook (e.g., start- and end date culture, brightfield images 3D structures). The results of this proof-of-concept study will be submitted for evaluation to the review committee. To establish a preliminary correlation between the ex vivo patient-derived prostate cancer 3D culture read-out an the clinical response of the patient. We expect to require at least 100 patients to obtain a meaningful insight into this correlation. We anticipate that approximately 50% of the enrolled patients are expected to receive the treatment evaluated in the read-out, a larger cohort is necessary to ensure sufficient sample size. To achieve the establishment ex vivo patient-derived prostate cancer 3D cultures of at least an additional 167 patients, the research protocol will be adapted where needed to obtain approval for the inclusion of another 500 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive analyses will be used to summarize the data and report the findings on tumorigenesis and drug response. For the selected patients who received the therapy which was screened for during the treatment read-out, the clinical response will be compared with the prediction and sensitivity, specificity, positive predictive value, negative predicted value, and the area under the (receiver operator) curve will be determined. | — |
Countries
Netherlands
Contacts
Public ContactIEWG Laven
Maastro
Outcome results
None listed