Detecting tiny amounts of prostate cancer left after 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)
This pilot will test whether a custom prostate-specific ctDNA blood test can find minimal residual disease after prostatectomy in men with high-risk prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT07334275 on ClinicalTrials.gov |
What this trial studies
This is an observational pilot enrolling men with high-risk or locally advanced prostate cancer who are scheduled for robot-assisted radical prostatectomy at participating Dutch centers. Researchers will collect tumor tissue and blood samples for biobanking and analyze circulating tumor DNA using a custom prostate-specific ctDNA panel. The presence of minimal residual disease (MRD) by ctDNA will be compared with later clinical recurrence to see if MRD detection improves prediction of relapse. No experimental treatments are given as part of this observational protocol.
Who should consider this trial
Good fit: Men aged 18 or older with high-risk localized or locally advanced prostate cancer who are scheduled for robot-assisted radical prostatectomy and willing to provide tissue and blood samples are ideal candidates.
Not a fit: Men with lower-risk disease, those not undergoing prostatectomy, or those unable to attend follow-up or provide blood samples are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could identify men at higher risk of recurrence earlier so follow-up and additional therapy can be better personalized.
How similar studies have performed: Early work in other cancers and emerging prostate-cancer studies show promising results for ctDNA MRD detection, but prostate-specific MRD testing remains relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nijmegen
- Prosper Prostate Cancer Clinics — Nijmegen, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.