Research Projects
Prostate Cancer
1. Prostate Cancer Clinical Trial（Phase III Multicenter Clinical Study）
2018.5.2-2019.11.27，Across four domestic centers (Changhai Hospital, Renji Hospital, Peking Union Medical College Hospital, and Changzheng Hospital), 110 patients were enrolled. Of these, 109 successfully underwent surgery, and 100 completed the 6-month follow-up with complete case report forms.
Inclusion Criteria：Low-Intermediate Risk（PSA<20ng/ml、T1a-T2c、Gleason≤7）；No seminal vesicle invasion, no capsular penetration, and no lymph node metastasis; overall survival exceeding 5 years.
Study Outcomes：At 6 months postoperatively, the local recurrence rate was 1%, with continence preservation achieved in 97% of patients and sexual function preserved in 91%. No major complications occurred, minimal blood loss was observed, and the average hospital stay ranged from 1 to 2 days.
| Follow-up Outcomes | Positive/Total(%) |
|---|---|
| Biopsy-proven residual tumor rate in the ablation zone at 6 months | 1/100,(1.0%) |
| Prostate-specific antigen (PSA) response rate at 6 months post-treatment | 100/100,(100%) |
| Proportion of patients with complete continence at 6-month follow-up | 97/100,(97.0%) |
| Proportion using ≤1 safety pad per day at 6-month follow-up | 100/100(100%) |
| Proportion maintaining baseline sexual function at 6-month follow-up | 91/100(91%) |
| Incidence of grade ≥4 adverse events (per CTCAE criteria) | 0/110,(0%) |
| Incidence of urinary tract infection | 14/110(12.3%) |
| Results | Baseline | 6-month postoperative |
|---|---|---|
| Incidence of clinically significant prostate cancer | / | 6% |
| Median PSA, ng/mL | 9.0(6.0-12.7) | 1.1(0.4-3.2) |
| Median IPSS score | 9.0(4.0-15.0) | 4.5(2.0-9.5) |
| Median IIEF-5 score | 2.0(1.0-18.0) | 2.0(0.5-12.5) |
| Pad-free rate | 99.1%(108/109) | 98%(98/100) |
The related findings were published in 2022 in JAMA Surgery (Journal of the American Medical Association Surgery), the premier journal in surgical science (TOP1 in surgery, Q1 in Medicine).
2. Post-marketing study in prostate cancer
Clinical data from 128 patients with localized prostate cancer treated with irreversible electroporation (IRE) between August 2019 and September 2023 at three tertiary hospitals: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, and Shanghai East Hospital Affiliated to Tongji University. All 128 procedures were successfully completed, with 116 patients (90.6%) completing 6-month postoperative follow-up.
Baseline Characteristics：Median age was 68 years (62-75); median PSA 8.64 ng/mL (5.83-12.57). Gleason scores were: 6 in 57 patients, 7 (intermediate risk) in 39 patients, and >7 (high risk) in 19 patients. Clinical T stages: T1c, T2a, T2b, T2c. Preoperative imaging showed no evidence of lymph node or distant organ metastasis.
Results： In the real-world setting, biochemical and radiographic recurrence rates within 6 months both remained below 7%. Specifically, the 6-month biochemical recurrence rate was 4.31%, radiographic recurrence rate 6.12%, and only 1.7% required short-term safety pad usage. No severe complications (CTCAE grade ≥3) occurred, with minimal intraoperative blood loss and a mean hospital stay of 1 to 2 days.
| Follow-up Data | Positive/Total(%) |
|---|---|
| Median PSA at 6 Months | 1.58 (0.56, 2.95) ng/ml |
| Biochemical recurrence at 6 months | 4.31%(5/116) |
| Radiographic recurrence at 6 months | 6.12%(6/98) |
| Postoperative pad-free rate | 96.08%(49/51) |
| postoperative complications | 7.76%(9/116) |
| T2 | Preoperatively  | 1 month postoperative | 6month postoperative |
| DWI | | | |
