Clinical trial Recruiting at 4 sites Observational Ages 55 and up Men only

Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback

Official title: An MRI-Based Diagnostic Model for Prostate Cancer Localization: An Exploratory Study Integrating Radiomics and the Metabolic Microenvironment

Run by Shanghai Zhongshan Hospital · NCT07856017 · Data updated 2026-11-12

Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.

Quick facts

Study typeObservational
Ages55 Years and up
SexMen only
Enrollment90 (estimated)
SponsorShanghai Zhongshan Hospital
Academic / other
Locations4 sites (Shanghai and 3 other locations)
StatusRecruiting
StartedJuly 21, 2026
Main results expectedAugust 31, 2027
Study endsAugust 31, 2028
Registry record updatedOctober 2, 2026
Trial IDNCT07856017 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 55 or older who are indicated for a prostate biopsy and have recent mpMRI, tPSA, and fPSA data available.

Probably not a fit

Patients with non-prostatic cancers, those with concurrent cancers affecting imaging, or those with severe cachexia or organ failure may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study seeks to integrate preoperative imaging data with intraoperative metabolic feedback to dynamically guide biopsy core placement in prostate cancer patients. The approach uses an intelligent system to adjust sampling decisions during the procedure based on real-time information. The study focuses on individualized sampling to potentially improve diagnostic accuracy while addressing safety and feasibility in an urban Chinese hospital network. Participants are men aged 55 and older undergoing a biopsy with available PSA measurements and mpMRI results within the prior month. Exclusion criteria target non-prostatic malignancies, concurrent cancers that affect imaging, and severe physiological compromise.

Why it matters

Potential benefit: If successful, the approach could improve biopsy targeting and diagnostic yield, leading to more accurate prostate cancer detection.

How similar studies have gone: Prior work in imaging-guided and adaptive sampling approaches shows promise, but this specific intraoperative metabolic-feedback system is novel in this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age ≥55 years;
2. Indication for prostate biopsy;
3. Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.

Exclusion Criteria:

1. Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
2. Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
3. Cachexia or organ function decompensation.

Where it's running

  • Minhang Hospital, Fudan University
    Shanghai, China
    Recruiting
  • Shanghai Geriatric Medical Center
    Shanghai, China
    Recruiting
  • Xuhui Hospital, Fudan University
    Shanghai, China
    Recruiting
  • Zhongshan Hospital, Fudan University
    Shanghai, China
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.