Detection of Minimal Residual Disease Post-prostatectomy
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male aged 18 years or older;
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;
Disqualifiers
Relevant contra-indications that may limit clinical follow-up or blood collection, as assessed by the including physician.
Trial population
Patients with high-risk prostate cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: High-risk localized prostate cancer or high-risk locally advanced prostate cancer
Trial outcomes
Primary outcomes
1
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 postoperatively2
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 postoperativelySecondary outcomes
1
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 postoperatively2
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 postoperatively3
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 postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Radboud University Medical Center
Lead sponsor
Catharina Ziekenhuis Eindhoven
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Maxima Medical Center
Collaborator
Source ClinicalTrials.gov