Development of an Intraoperative Adaptive Biopsy System for Prostate Cancer: Integrating Imaging Navigation With Metabolic Feedback for Dynamic Decision-Making

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age55+
SponsorShanghai Zhongshan Hospital

About this trial

Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Adaptive Biopsy Group
Group B: Systemic Biopsy Group
Group C: mpMRI Fusion Targeted Biopsy Group

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Prostate cancer detection rate

Time frame
After 8 weeks of the enrollment process was completed
2

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
3

The time of biopsy

Time frame
After 8 weeks of the enrollment process was completed
4

Complication rate

Time frame
After 8 weeks of the enrollment process was completed

Other outcomes

Sponsors and contacts

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