Detection of Minimal Residual Disease Post-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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07334275

Acronym

MiRaDE

Enrollment

Registered

2026-01-12

Start date

2025-09-16

Completion date

2028-01-31

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Prostatectomy, Circulating tumor DNA

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The proportion of high-risk prostate cancer patients in which ctDNA-detected minimal residual disease (MRD) exceeds 15%	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	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)

Secondary

Measure	Time frame	Description
The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients	From enrollment to 12 months postoperatively	To determine the proportion of HR-PCa with ctDNA-detected early relapse at 12 weeks postoperatively
The relation between ctDNA% and distant disease-free survival (DDFS)	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
The relation between poor prognostic gene signature (TP53 and/or PTEN) and/or DNA damage repair alterations and distant disease-free survival (DDFS)	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

Countries

Netherlands

Outcome results