Detection of Minimal Residual Disease Post-prostatectomy (MiRaDE)

Radboud University Medical Center

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07334275

2025-18163

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

High-risk localized prostate cancer or high-risk locally advanced prostate cancer

Description:

Included patients will have: 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).