Prostate CancerNCT06509919
Application of a Novel Model Based on Plasma cfDNA Assay and MRl Imaging in the Detection of Prostate Cancer
An observational study of Prostate Cancer, run by Shanghai Changzheng Hospital at 10 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Blood draw and MRI scans
- How many people
- 1,600 participants
- Where
- 10 sitesChina
- Study dates
- 9 Jul 2024to Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients aged 18-80 with PSA tests score of 4-10 ng/ml and are scheduled for a prostate biopsy.
Who may be able to join
- Male, 18-80 years old;
- PSA: 4-10ng/ml;
- 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).
Who cannot join
- 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;
- 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;
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- 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;
- 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;
- Patients who, in the judgment of the investigator, are not suitable for participation in this clinical trial;
- Patients who meet any of the above criteria may not be included as subjects.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Ningbo No. 1 Hospital
Ningbo, Zhejiang, 315010
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Changzheng hospital
Shanghai, Shanghai Municipality, 201109
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
About this study
Official title: Application of a Novel Model Based on Plasma cfDNA Assay and MRl Lmaging in the Detection of Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Blood draw and MRI scans
- Keywords
- Elevated PSA, Biopsy, Prostate cancer, Prostate neoplasms, cfDNA, Machine learning
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw and MRI scansDiagnostic test
Before undergoing a prostate biopsy, participants will have about 10 mLs of venous blood drawn. Blood will be sent to Geneseeq Technology Inc. for whole genome high-throughput sequencing of plasma cfDNA.
MRI scans obtained prior to prostate biopsy will be collected following informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Patients with elevated PSA test results (4-10ng/ml) | Not described Receives: Diagnostic Test: Blood draw and MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Measured: Through completion of study and all data analysis which may take up to one and a half years.
Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Measured: Through completion of study and all data analysis which may take up to one and a half years.
Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Measured: Through completion of study and all data analysis which may take up to one and a half years.
Secondary outcomes (1)
AUROC value for predicting clinically significant prostate cancer in pathological results.
Measured: Through completion of study and all data analysis which may take up to one and a half years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start9 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Modifications to trial design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No. 1 Hospital, The First Affiliated Hospital of Guangzhou Medical University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Soochow University, West China Hospital, Zhongda Hospital, Northern Jiangsu People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Responsible party
- Principal investigator, Ren Shancheng, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509919
- Sponsor's protocol ID
- KAL1
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Novel Model Based on Plasma cfDNA Assay and MRl Lmaging in the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06509919
- Acronym / sponsor ID
- KAL1
- Conditions
- Prostate Cancer
- Keywords
- Elevated PSA, Biopsy, Prostate cancer, Prostate neoplasms, cfDNA, Machine learning
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Modifications to trial design
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Ningbo No. 1 Hospital, The First Affiliated Hospital of Guangzhou Medical University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Soochow University, West China Hospital, Zhongda Hospital, Northern Jiangsu People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with elevated PSA test results (4-10ng/ml) | – | Diagnostic Test: Blood draw and MRI scans |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients aged 18-80 with PSA tests score of 4-10 ng/ml and are scheduled for a prostate biopsy.
Key inclusion criteria (4 listed)
- Male, 18-80 years old;
- PSA: 4-10ng/ml;
- Patients scheduled for prostate biopsy：
Key exclusion criteria (11 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw and MRI scansBefore undergoing a prostate biopsy, participants will have about 10 mLs of venous blood drawn. Blood will be sent to Geneseeq Technology Inc. for whole genome high-throughput sequencing of plasma cfDNA. MRI scans obtained prior to prostate biopsy will be collected following informed consent. | Diagnostic test | Patients with elevated PSA test results (4-10ng/ml) |
Primary outcome
AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Time frame: Through completion of study and all data analysis which may take up to one and a half years.
Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Time frame: Through completion of study and all data analysis which may take up to one and a half years.
Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
Time frame: Through completion of study and all data analysis which may take up to one and a half years.
1 secondary outcome
AUROC value for predicting clinically significant prostate cancer in pathological results.
Time frame: Through completion of study and all data analysis which may take up to one and a half years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Shanghai Changzheng Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone. (time frame: Through completion of study and all data analysis which may take up to one and a half years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.