Application of a Novel Model Based on Plasma cfDNA Assay and MRl Imaging in the Detection of Pros… (NCT06509919) | Clinical Trial Compass
SuspendedNot Applicable
Application of a Novel Model Based on Plasma cfDNA Assay and MRl Imaging in the Detection of Prostate Cancer
Stopped: Modifications to trial design
China1,600 participantsStarted 2024-07-09
Plain-language summary
The goal of this diagnostic test is to obtain multiple cell-free DNA （cfDNA） fragment profiles of subjects by whole genome sequencing based on plasma cfDNA, build a prostate cancer prediction model by machine learning, and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigen（PSA） or clinical or imaging evidence. Therefore, this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA "gray zone" (4-10 ng/ml) in the diagnosis of prostate cancer and patients with clinically significant prostate cancer.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male, 18-80 years old;
. PSA: 4-10ng/ml;
. Patients scheduled for prostate biopsy：
Exclusion criteria
. Patients with a prior diagnosis of any malignancy within 5 years;
. Patients who have undergone prior transurethral resection or enucleation of the prostate;
. Patients who have received prior treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, and immunotherapy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Timeframe: Through completion of study and all data analysis which may take up to one and a half years.
2
Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Timeframe: Through completion of study and all data analysis which may take up to one and a half years.
3
Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Timeframe: Through completion of study and all data analysis which may take up to one and a half years.
. Patients with long-term use of anticoagulant and antiplatelet aggregation drugs (anticoagulant discontinued for less than 1 week);
. Received any form of oncological treatment, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, and immunotherapy prior to enrollment for blood sampling;
. concurrently suffering from other serious systemic diseases that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immune, urinary and other systemic diseases;
. Organ transplant recipients or prior non-autologous (allogeneic) bone marrow or stem cell transplant population;
. Subjects who have had a blood transfusion 1 month prior to the blood draw;