Detection of Minimal Residual Disease Post-prostatectomy
Recruiting · NCT07334275 · Observational (researchers observe without assigning treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Male aged 18 years or older;
- High-risk prostate cancer, defined as:
- 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
- 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.
Where it is running
1 location listed.
- Prosper Prostate Cancer Clinics - Nijmegen, Netherlands