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Detection of Minimal Residual Disease Post-prostatectomy

Sponsored by Radboud University Medical Center

About this trial

Last updated 3 months ago

Study ID

2025-18163

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18+ Years
Male

Trial Timing

Started 7 months ago

What is this trial about?

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.

What are the participation requirements?

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.