Prostate CancerMiRaDENCT07334275
Detection of Minimal Residual Disease Post-prostatectomy
An observational study of Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Sep 2025to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high-risk prostate cancer
Who may be able to join
- 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.
Who cannot join
- Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Prosper Prostate Cancer Clinics
Nijmegen
M.J. van der Doelen, MD, PhD, +31 24 365 8961, m.vanderdoelen@cwz.nl
Niven Mehra, MD, PhD, Niven.Mehra@radboudumc.nl
About this study
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)
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.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostatectomy, Circulating tumor DNA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15%
To determine the proportion of high-risk prostate cancer patients with ctDNA-detected minimal residual disease (MRD) at six weeks postoperatively
Measured: From enrollment to 6 weeks postoperatively
The relation between distant disease-free survival (DDFS) <12 months and minimal residual disease (MRD) positive patients
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)
Measured: From enrollment to 12 months postoperatively
Secondary outcomes (3)
The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients
To determine the proportion of HR-PCa with ctDNA-detected early relapse at 12 weeks postoperatively
Measured: From enrollment to 12 months postoperatively
The relation between ctDNA% and distant disease-free survival (DDFS)
To determine the preoperative ctDNA fractional abundance (ctDNA%) and the prognostic characteristics of ctDNA% related to early relapse and radiological disease-free survival
Measured: 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)
To determine whether mutations in TP53, PTEN and DNA damage repair are associated with early distant metastasis-free survival
Measured: From enrollment to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start16 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Maxima Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334275
- Sponsor's protocol ID
- 2025-18163
- Other IDs
- 2025
- Acronym
- MiRaDE
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07334275
- Acronym / sponsor ID
- MiRaDE / 2025-18163
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostatectomy, Circulating tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Maxima Medical Center
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high-risk prostate cancer
Key inclusion criteria (6 listed)
- Male aged 18 years or older;
- High-risk prostate cancer, defined as:
- Scheduled for robot-assisted radical prostatectomy;
- Willingness to consent to both patient information sheets regarding tissue and liquid biobanking.
Key exclusion criteria (1 listed)
- Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
3 secondary outcomes
The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients
Time frame: From enrollment to 12 months postoperatively
The relation between ctDNA% and distant disease-free survival (DDFS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.