The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy

NCT03838432 | Unknown DMC

• 1 other identifier: BZLC-12-1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

focal therapy; IRE; Composite Steep-pulse Treatment Apparatus; prostate cancer; Multi-center

Outcome Measures

Primary Outcomes (2)

• The result of prostate maping biopsy

  evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer

  6 Months

• The result of prostate MRI

  evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions

  6 Months

Secondary Outcomes (4)

• urinary incontinence

  6 Months

• urination function(IPSS scoring)

  6 Months

• sexual function (IIEF-5 scoring)

  6 Months

• urinary catheter retention time

  6 Months

Study Arms (1)

Steep Pulse Device

EXPERIMENTAL

Applying the steep pulse to treat the patients with Prostate cancer

Device: Steep Pulse Device

Interventions

Steep Pulse Device DEVICE

Applying the steep pulse to treat the patients with Prostate cancer

Steep Pulse Device

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The therapy must be thoroughtly understood with the agreement signed
• Prostate MRI can identify negative extracapsular extension and seminal vesicle involvement,and no evidence of lymphatic metastasis
• Patients must have confirmed prostate cancer by prostate maping biopsy
• Low-risk or intermediate risk prostate cancer(PSA\<20ng/ml,T1a-T2c,Gleason Score≤7)
• There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
• No prostatic calculus or prostatic calculus≤5mm
• Age ≥ 40 - ≤ 85 years
• Life expectancy of greater than 5 years(WHO Performance Status 0-1)
• Patients with fertility are willing to take contraceptive measures until the end of the trial

You may not qualify if:

• Patients have previously undergone radical prostatectomy, hormonal therapy or radiotherapy.
• Patients underwent other surgery before less than 3 months.
• Patients required long-term medication with anticoagulans or stop taking anticoagulans less than 1 months
• Patients with clinically significant cardiovascular disease or other serious diseases
• 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.
• Patients with history of epilepsy
• Patients with other malignant tumor or patients with hiv.
• Patients with other serious systemic diseases that the study believes may interfere with the treatment, evaluation, and compliance of the trial;
• Patients with participation in another clinical trial less than 3 months.
• Patients with the judge that they are not suitable for this clinical trial

Sponsors & Collaborators

• Second Military Medical University: lead
• RenJi Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Zhejiang University: collaborator

Study Sites (1)

Changhai Hospital,Second Military Medical University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (2)

• Wang 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 DERIVED

• He 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director, head of uroglogy department, clinical professor

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: February 12, 2019
• Study Start: May 2, 2018
• Primary Completion: September 27, 2019
• Study Completion: January 18, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

CN (1)