Prostate Cancer (Adenocarcinoma)NCT07856017
Development of an Intraoperative Adaptive Biopsy System for Prostate Cancer: Integrating Imaging Navigation With Metabolic Feedback for Dynamic Decision-Making
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Cancer (Diagnosis), run by Shanghai Zhongshan Hospital at 4 sites in China.
Trial summary
Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis)
- How many people
- 90 participants
- Where
- 4 sitesChina
- Study dates
- 21 Jul 2026to 31 Aug 2028
- Phase
- Observational
- 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 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent prostate biopsy at three medical centers in Shanghai: Minhang Hospital, Fudan University; Xuhui Hospital, Fudan University and Shanghai Geriatric Medical Center
Who may be able to join
- Age ≥55 years;
- Indication for prostate biopsy;
- Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.
Who cannot join
- Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
- Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
- Cachexia or organ function decompensation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Minhang Hospital, Fudan University
Shanghai
Minhang Hospital, Fudan University, +86 64923400, zsyhuangjq@163.com
- Recruiting
Shanghai Geriatric Medical Center
Shanghai
Shanghai Geriatric Medical Center, +86 51371990, zsurology@126.com
- Recruiting
Xuhui Hospital, Fudan University
Shanghai
Xuhui Hospital, Fudan University, +86 36682220, wang.hang@zs-hospital.sh.cn
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Zhongshan Hospital, Fudan University, +86 64041990, wang.hang@zs-hospital.sh.cn
About this study
Official title: An MRI-Based Diagnostic Model for Prostate Cancer Localization: An Exploratory Study Integrating Radiomics and the Metabolic Microenvironment
Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Biopsy Group | Adaptive dynamic biopsy is performed using an intelligent system integrating preoperative imaging data with real-time intraoperative metabolic feedback. | |
| Systemic Biopsy Group | A 10-12-core systematic biopsy. | |
| mpMRI Fusion Targeted Biopsy Group | mpMRI-US fusion-guided targeted prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group
Measured: After 8 weeks of the enrollment process was completed
Secondary outcomes (4)
Prostate cancer detection rate
Measured: After 8 weeks of the enrollment process was completed
Missed diagnosis rates in the adaptive biopsy group and the mpMRI-US fusion-targeted biopsy group
Measured: After 8 weeks of the enrollment process was completed
The time of biopsy
Measured: After 8 weeks of the enrollment process was completed
Complication rate
Measured: After 8 weeks of the enrollment process was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start21 Jul 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hang Wang, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856017
- Sponsor's protocol ID
- 2026-006-01K
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An MRI-Based Diagnostic Model for Prostate Cancer Localization: An Exploratory Study Integrating Radiomics and the Metabolic Microenvironment
- ClinicalTrials.gov ID
- NCT07856017
- Acronym / sponsor ID
- 2026-006-01K
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 2 Oct 2026 (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.
Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptive Biopsy Group | – | –Adaptive dynamic biopsy is performed using an intelligent system integrating preoperative imaging data with real-time intraoperative metabolic feedback. |
| Systemic Biopsy Group | – | –A 10-12-core systematic biopsy. |
| mpMRI Fusion Targeted Biopsy Group | – | –mpMRI-US fusion-guided targeted prostate biopsy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent prostate biopsy at three medical centers in Shanghai: Minhang Hospital, Fudan University; Xuhui Hospital, Fudan University and Shanghai Geriatric Medical Center
Key inclusion criteria (3 listed)
- Age ≥55 years;
- Indication for prostate biopsy;
- Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.
Key exclusion criteria (3 listed)
- Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
- Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
- Cachexia or organ function decompensation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group
Time frame: After 8 weeks of the enrollment process was completed
4 secondary outcomes
Prostate cancer detection rate
Time frame: After 8 weeks of the enrollment process was completed
Missed diagnosis rates in the adaptive biopsy group and the mpMRI-US fusion-targeted biopsy group
Time frame: After 8 weeks of the enrollment process was completed
The time of biopsy
Time frame: After 8 weeks of the enrollment process was completed
Complication rate
Time frame: After 8 weeks of the enrollment process was completed
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 2 Oct 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.
4 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 (Adenocarcinoma) and Prostate Cancer (Diagnosis), run by Shanghai Zhongshan Hospital at 4 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 3 inclusion and 3 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group (time frame: After 8 weeks of the enrollment process was completed). 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 2 Oct 2026.