NCT07334275

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Sep 2025Jan 2028

Study Start

First participant enrolled

September 16, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

December 31, 2025

Last Update Submit

December 31, 2025

Conditions

Prostate Cancer

Keywords

Prostate cancerProstatectomyCirculating tumor DNA

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    From enrollment to 12 months postoperatively

Secondary Outcomes (3)

  • The relation between distant disease-free survival (DDFS) and 12-week ctDNA-positive patients

    From enrollment to 12 months postoperatively

  • The relation between ctDNA% and distant disease-free survival (DDFS)

    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)

    From enrollment to 12 months postoperatively

Study Arms (1)

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).

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with high-risk prostate cancer

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prosper Prostate Cancer Clinics

Nijmegen, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA (ctDNA)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 12, 2026

Study Start

September 16, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations

NL(1)