Detection of Minimal Residual Disease Post-prostatectomy

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)

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.

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.