Clinical Trials in the Netherlands / NCT07334275
Recruiting
Observational
Detection of Minimal Residual Disease Post-prostatectomy
NCT07334275 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Prostate Cancer
Study summary
The clinical objective for this pilot study is to determine whether minimal residual disease (MRD) detection in high-risk prostate cancer, utilizing a custom-made prostate-specific circulating tumor DNA (ctDNA) panel, may lead to more optimal prediction of disease recurrence following radical prostatectomy.
Eligibility
Inclusion Criteria:
* Male aged 18 years or older;
* High-risk prostate cancer, defined as:
1. High-risk localized prostate cancer, with PSA level \>20 ng/mL, Gleason score 8-10 (ISUP grade 4/5) at prostate biopsies, or iT3a (based on multi-parametric MRI of the prostate); or
2. High-risk locally advanced prostate cancer, having any PSA level, any Gleason score/ISUP grade, iT3b-4 (based on multi-parametric MRI of the prostate) or iN1 (based on PSMA PET/CT imaging);
* Scheduled for robot-assisted radical prostatectomy;
* Willingness to consent to both patient information sheets regarding tissue and liquid biobanking.
Exclusion Criteria:
* Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.
Primary outcome measure(s)
- The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15% — From enrollment to 6 weeks postoperatively
To determine the proportion of high-risk prostate cancer patients with ctDNA-detected minimal residual disease (MRD) at six weeks postoperatively - The relation between distant disease-free survival (DDFS) <12 months and minimal residual disease (MRD) positive patients — From enrollment to 12 months postoperatively
To determine the risk of early relapse (radiological distant disease-free survival within twelve months following prostatectomy) in patients with and without ctDNA-detected minimal residual disease (MRD)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Prosper Prostate Cancer Clinics | Nijmegen | Netherlands | Recruiting |
More Radboud University Medical Center trials in the Netherlands
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07334275 on ClinicalTrials.gov ↗ ← All trials in the Netherlands