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Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Detecting tiny amounts of prostate cancer left after prostatectomy

Official title: 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)

Run by Radboud University Medical Center · NCT07334275 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexMen only
Enrollment50 (estimated)
SponsorRadboud University Medical Center
Academic / other
Locations1 site (Nijmegen)
StatusRecruiting
StartedSeptember 16, 2025
Main results expectedJuly 2027
Study endsJanuary 2028
Registry record updatedJanuary 12, 2026
Trial IDNCT07334275 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Prosper Prostate Cancer Clinics
    Nijmegen, Netherlands     Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.