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Blood DNA fragments and MRI join forces to spot hidden prostate cancer

NCT ID NCT06509919

Diagnosis Sponsor: Shanghai Changzheng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether combining a blood test that analyzes DNA fragments (cfDNA) with MRI scans can better detect prostate cancer in men with borderline PSA levels (4–10 ng/mL). Researchers aim to build a prediction model that could reduce unnecessary biopsies. The study involves 1,600 men scheduled for prostate biopsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood draw for plasma cfDNA whole genome sequencing and MRI scans
What this could lead to
If successful, this could provide a more accurate, non-invasive way to detect prostate cancer and reduce unnecessary biopsies.
What could go wrong
This is an early-stage diagnostic model that may not prove accurate enough in practice. The blood test and MRI are not treatments and carry no direct benefit to participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Male patients aged 18-80 with PSA tests score of 4-10 ng/ml and are scheduled for a prostate biopsy.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male, 18-80 years old; 2. PSA: 4-10ng/ml; 3. Patients scheduled for prostate biopsy： * fPSA（free PSA）/PSA \< 0.16 or PSAD（PSA density） \> 0.15 (ng/mL/cm³) or PSAV（PSA velocity） \> 0.75 (ng/mL/year) ② positive DRE （digital rectal examination） ③suspicious positive lesions on ultrasound/MRI). Exclusion Criteria: 1. Patients with a prior diagnosis of any malignancy within 5 years; 2. Patients who have undergone prior transurethral resection or enucleation of the prostate; 3. Patients who have received prior treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, and immunotherapy; 4. Patients with long-term use of anticoagulant and antiplatelet aggregation drugs (anticoagulant discontinued for less than 1 week); 5. Received any form of oncological treatment, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, and immunotherapy prior to enrollment for blood sampling; 6. 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; 7. Organ transplant recipients or prior non-autologous (allogeneic) bone marrow or stem cell transplant population; 8. Subjects who have had a blood transfusion 1 month prior to the blood draw; 9. Patients who are participating in other clinical trials, or who have participated in other clinical trials that have been completed less than 1 year ago; 10. Patients who, in the judgment of the investigator, are not suitable for participation in this clinical trial; 11. Patients who meet any of the above criteria may not be included as subjects.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Changzheng hospital

    Shanghai, Shanghai Municipality, 201109, China

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029, China

  • Ningbo No. 1 Hospital

    Ningbo, Zhejiang, 315010, China

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001, China

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009, China

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