RecruitingRecruiting
Detection of Minimal Residual Disease Post-prostatectomy
NCT07334275 · Radboud University Medical Center
In plain English
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Official title
Pilot Study for the Detection of Minimal Residual Disease Post-prostatectomy and Early Disease Recurrence in Circulating Tumor DNA to Guide Future Adjuvant Therapy in High-risk Prostate Cancer Patients (MiRaDE)
About this study
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 criteria
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.
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-09-16
Estimated completion: 2028-01
Last updated: 2026-01-12
Primary outcomes
- • The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15% (From enrollment to 6 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)
Sponsor
Radboud University Medical Center · other
With: Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Maxima Medical Center
All locations (1)
Prosper Prostate Cancer ClinicsRecruiting
Nijmegen, Netherlands