Detection of Minimal Residual Disease Post-prostatectomy (MiRaDE)

December 31, 2025 updated by: Radboud University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with high-risk prostate cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High-risk localized prostate cancer or high-risk locally advanced prostate cancer

Included patients will have:

  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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15%
Time Frame: From enrollment to 6 weeks postoperatively
To determine the proportion of high-risk prostate cancer patients with ctDNA-detected minimal residual disease (MRD) at six weeks postoperatively
From enrollment to 6 weeks postoperatively
The relation between distant disease-free survival (DDFS) <12 months and minimal residual disease (MRD) positive patients
Time Frame: From enrollment to 12 months postoperatively
To determine the risk of early relapse (radiological distant disease-free survival within twelve months following prostatectomy) in patients with and without ctDNA-detected minimal residual disease (MRD)
From enrollment to 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients
Time Frame: From enrollment to 12 months postoperatively
To determine the proportion of HR-PCa with ctDNA-detected early relapse at 12 weeks postoperatively
From enrollment to 12 months postoperatively
The relation between ctDNA% and distant disease-free survival (DDFS)
Time Frame: From enrollment to 12 months postoperatively
To determine the preoperative ctDNA fractional abundance (ctDNA%) and the prognostic characteristics of ctDNA% related to early relapse and radiological disease-free survival
From enrollment to 12 months postoperatively
The relation between poor prognostic gene signature (TP53 and/or PTEN) and/or DNA damage repair alterations and distant disease-free survival (DDFS)
Time Frame: From enrollment to 12 months postoperatively
To determine whether mutations in TP53, PTEN and DNA damage repair are associated with early distant metastasis-free survival
From enrollment to 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Catharina Ziekenhuis Eindhoven
Maxima Medical Center
Canisius-Wilhelmina Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-18163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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