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NCT Number: NCT07334275

Detection of Minimal Residual Disease Post-prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Catharina Ziekenhuis Eindhoven
  • Maxima Medical Center

Registry information

Official study 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)

Acronym: MiRaDE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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