Detection of Minimal Residual Disease Post-prostatectomy

Radboud University Medical Center50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Prosper Prostate Cancer Clinics

Nijmegen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: From enrollment to 12 months postoperatively

Secondary Outcomes

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

Time frame: 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

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)

To determine whether mutations in TP53, PTEN and DNA damage repair are associated with early distant metastasis-free survival

Time frame: From enrollment to 12 months postoperatively

Data from ClinicalTrials.gov

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