RECRUITINGOBSERVATIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Locations (1)
Prosper Prostate Cancer Clinics
Nijmegen, Netherlands