Prostate AdenocarcinomaNCT05998278
Personalized Optimization of Systematic Prostate Biopsy
A study testing Personalized Optimization of Systematic Prostate Biopsy in people with Prostate Adenocarcinoma, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. Read more about this study
- Who is it for?
- Ages 50 to 95 years, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Personalized Optimization of Systematic Prostate Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lesions found on rectal examination with any PSA value;
- Patients with abnormal lesions found on imaging with any PSA value;
- PSA >10.0 ng.ml-1;
- Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA < 0.16; (5 ) mpMRI was performed prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1) assessment category ≥3
- Willing to truthfully fill in the subject survey scale; (7) Willing to undergo follow-up; (8) The patient himself or his authorized immediate family member has signed the informed consent for clinical trial.
Who cannot join
- previous biopsy cases;
- Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
- Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
- clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
- unable to follow the plan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, 350000
Jiabing Zheng, +8613799422519, xhyykjk@163.com
About this study
Official title: Diagnostic Performance of a Individualized Reduced-Core Biopsy Strategy in Prostate Cancer: A Prospective, Randomized Controlled Study
Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. On the basis of establishing a model with DRS stratification to reduce the cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that through this prospective study to verify the efficacy of the model and provide patients with a new biopsy model with high accuracy and fewer complications.
In this study， patients with suspected prostate cancer were randomly divided into two groups. Experimental group received targeted biopsy combined personalized systematic biopsy, and the control group received systematic biopsy .The differences of the detection rate of Prostate cancer between the two groups were compared.
Read the detailed description
In this study, patients with suspected prostate cancer were were enrolled at our institution, a public referral tertiary center. After written consent was obtained，Patients were randomly assigned to the intervention or control group in a 1:1 ratio by a research nurse who was not involved in the clinical study, using Computer-generated randomization method. Once the allocation was established, neither patients nor investigators, including the member of the study who collected the data related to infectious events later, were blinded. Prior to biopsy, the following patient characteristics were obtained: age, BMI, serum PSA levels, location and size of the region of interest, and PIRADS-V2 score. Biopsy was performed by an experienced urologist using standard transperineal technique. The patient was placed in the lithotomy position and underwent either general anesthesia or local anesthesia (15 ml of 5% lidocaine was injected into the prostate capsule and apex under ultrasound guidance after the ultrasound probe was inserted transrectally for local anesthesia). Patients assigned to the experimental group were informed of the personalized systematic biopsy combined with targeted biopsy using the (12 cores -x) model (https://daringsky.shinyapps.io/prediction_v2/)， and the control group received systematic biopsy. A biopsy core was obtained using an 18-gauge 25cm needle and a spring needle biopsy gun. The primary endpoint was the rate of prostate cancer diagnosis, including clinically significant cases. The secondary endpoints included pain scores and complications such as hematuria, perineal hematoma, urinary tract infection, and urinary retention.
An interim analysis is planned after approximately 50% of the target sample size has completed follow-up for the primary endpoint. The interim analysis aims to:
- assess safety data to ensure participant protection, and
- explore preliminary efficacy trends.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Personalized Optimization of Systematic Prostate Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Optimization of Systematic Prostate BiopsyProcedure or surgery
Login the model based on our previous study (https://daringsky.shinyapps.io/prediction_v2/) allows for input of age, BMI, serum PSA, size and location of suspicious lesions, PIRADS - V2 score, and prostate volume to generate an individualized needle distribution map,then targeted biopsy combined personalized optimization of systematic prostate biopsy was performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group received targeted biopsy plus personalized systematic biopsy Receives: Procedure: Personalized Optimization of Systematic Prostate Biopsy |
| Control group | No intervention | Control group received systematic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of clinically significant prostate cancer.
According to the pathological results after biopsy, the detection rate of clinically significant prostate cancer (csPCa) was calculated.
Measured: 3 months after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start23 Aug 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- They were randomly divided into two groups. One group received systematic biopsy. The other group received Targeted biopsy + personalized reduced-core biopsy .
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenlin Chen, Principal investigator, Department of Urology, Fujian Union Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998278
- Sponsor's protocol ID
- 2022WSJK030
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Z, Qu M, Shen X, Jiang S, Zhang W, Ji J, Wang Y, Zhang J, Chen Z, Lin L, Li M, Wu C, Gao X. Establishment of an Individualized Predictive Model to Reduce the Core Number for Systematic Prostate Biopsy: A Dual Center Study Based on Stratification of the Disease Risk Score. Front Oncol. 2022 Feb 14;11:831603. doi: 10.3389/fonc.2021.831603. eCollection 2021.
PubMed 35237503
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of a Individualized Reduced-Core Biopsy Strategy in Prostate Cancer: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05998278
- Acronym / sponsor ID
- 2022WSJK030
- Conditions
- Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Aug 2023 (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.
Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. On the basis of establishing a model with DRS stratification to reduce the cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that through this prospective study to verify the efficacy of the model and provide patients with a new biopsy model with high accuracy and fewer complications.
In this study， patients with suspected prostate cancer were randomly divided into two groups. Experimental group received targeted biopsy combined personalized systematic biopsy, and the control group received systematic biopsy .The differences of the detection rate of Prostate cancer between the two groups were compared.
Detailed description
In this study, patients with suspected prostate cancer were were enrolled at our institution, a public referral tertiary center. After written consent was obtained，Patients were randomly assigned to the intervention or control group in a 1:1 ratio by a research nurse who was not involved in the clinical study, using Computer-generated randomization method. Once the allocation was established, neither patients nor investigators, including the member of the study who collected the data related to infectious events later, were blinded. Prior to biopsy, the following patient characteristics were obtained: age, BMI, serum PSA levels, location and size of the region of interest, and PIRADS-V2 score. Biopsy was performed by an experienced urologist using standard transperineal technique. The patient was placed in the lithotomy position and underwent either general anesthesia or local anesthesia (15 ml of 5% lidocaine was injected into the prostate capsule and apex under ultrasound guidance after the ultrasound probe was inserted transrectally for local anesthesia). Patients assigned to the experimental group were informed of the personalized systematic biopsy combined with targeted biopsy using the (12 cores -x) model (https://daringsky.shinyapps.io/prediction_v2/)， and the control group received systematic biopsy. A biopsy core was obtained using an 18-gauge 25cm needle and a spring needle biopsy gun. The primary endpoint was the rate of prostate cancer diagnosis, including clinically significant cases. The secondary endpoints included pain scores and complications such as hematuria, perineal hematoma, urinary tract infection, and urinary retention.
An interim analysis is planned after approximately 50% of the target sample size has completed follow-up for the primary endpoint. The interim analysis aims to:
- assess safety data to ensure participant protection, and
- explore preliminary efficacy trends.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- They were randomly divided into two groups. One group received systematic biopsy. The other group received Targeted biopsy + personalized reduced-core biopsy .
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Personalized Optimization of Systematic Prostate BiopsyExperimental group received targeted biopsy plus personalized systematic biopsy |
| Control group | No intervention | –Control group received systematic biopsy |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with lesions found on rectal examination with any PSA value;
- Patients with abnormal lesions found on imaging with any PSA value;
- PSA >10.0 ng.ml-1;
- Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA < 0.16; (5 ) mpMRI was performed prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1) assessment category ≥3
- Willing to truthfully fill in the subject survey scale; (7) Willing to undergo follow-up; (8) The patient himself or his authorized immediate family member has signed the informed consent for clinical trial.
Key exclusion criteria (5 listed)
- previous biopsy cases;
- Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
- Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
- clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
- unable to follow the plan.
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 |
|---|---|---|
| Personalized Optimization of Systematic Prostate BiopsyLogin the model based on our previous study (https://daringsky.shinyapps.io/prediction_v2/) allows for input of age, BMI, serum PSA, size and location of suspicious lesions, PIRADS - V2 score, and prostate volume to generate an individualized needle distribution map,then targeted biopsy combined personalized optimization of systematic prostate biopsy was performed. | Procedure or surgery | Experimental group |
Primary outcome
The detection rate of clinically significant prostate cancer.
Time frame: 3 months after biopsy
According to the pathological results after biopsy, the detection rate of clinically significant prostate cancer (csPCa) was calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 35237503Chen Z, Qu M, Shen X, Jiang S, Zhang W, Ji J, Wang Y, Zhang J, Chen Z, Lin L, Li M, Wu C, Gao X. Establishment of an Individualized Predictive Model to Reduce the Core Number for Systematic Prostate Biopsy: A Dual Center Study Based on Stratification of the Disease Risk Score. Front Oncol. 2022 Feb 14;11:831603. doi: 10.3389/fonc.2021.831603. eCollection 2021.
- 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.
Zhenlin Chen principal investigator
Department of Urology, Fujian Union Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Optimization of Systematic Prostate Biopsy in people with Prostate Adenocarcinoma, run by Fujian Medical University Union Hospital at 1 site 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiabing Zheng (+8613799422519, xhyykjk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of clinically significant prostate cancer. (time frame: 3 months after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998278, which also lists 1 linked publication.
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 18 Dec 2025.