Clinical trial · Interventional
The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy
The Efficacy and Safety of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Apparatus Used in Prostate Cancer Ablation Therapy : a Multicenter, Single-arm, Objective Performance Criteria Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is studying the effects and safety in treating patients from five different centers with local prostate cancer, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Steep Pulse Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Steep Pulse Device
- description
- Applying the steep pulse to treat the patients with Prostate cancer
- interventionNames
- Device: Steep Pulse Device
Primary outcomes (2)
- measure
- The result of prostate maping biopsy
- timeFrame
- 6 Months
- description
- evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer
- measure
- The result of prostate MRI
- timeFrame
- 6 Months
- description
- evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The therapy must be thoroughtly understood with the agreement signed 2. Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis 3. Patients must have confirmed prostate cancer by prostate maping biopsy 4. Low-risk or intermediate risk prostate cancer(PSA\<20ng/ml,T1a-T2c,Gleason Score≤7) 5. There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI 6. No prostatic calculus or prostatic calculus≤5mm 7. Age ≥ 40 - ≤ 85 years 8. Life expectancy of greater than 5 years(WHO Performance Status 0-1) 9. Patients with fertility are willing to take contraceptive measures until the end of the trial Exclusion Criteria: 1. Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy. 2. Patients underwent other surgery before less than 3 months. 3. Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months 4. Patients with clinically significant cardiovascular disease or other serious diseases 5. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs. 6. Patients with history of epilepsy 7. Patients with other malignant tumor or patients with hiv. 8. Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial; 9. Patients with participation in another clinical trial less than 3 months. 10. Patients with the judge that they are not suitable for this clinical trial
References
Publications (2)
- DERIVEDWang H, Xue W, Yan W, Yin L, Dong B, He B, Yu Y, Shi W, Zhou Z, Lin H, Zhou Y, Wang Y, Shi Z, Ren S, Gao X, Wang L, Xu C. Extended Focal Ablation of Localized Prostate Cancer With High-Frequency Irreversible Electroporation: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Aug 1;157(8):693-700. doi: 10.1001/jamasurg.2022.2230. PMID 35793110
- DERIVEDHe BM, Xue W, Yan WG, Yin L, Dong BJ, Zhou ZE, Lin HZ, Zhou Y, Wang YQ, Shi ZK, Zhou H, Wang SD, Ren SC, Gao X, Wang LH, Xu CL, Wang HF. A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol. Front Oncol. 2021 Nov 10;11:760003. doi: 10.3389/fonc.2021.760003. eCollection 2021. PMID 34858837