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Prostate CancerNCT03838432

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

A study testing Steep Pulse Device in people with Prostate Cancer, run by Second Military Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Steep Pulse Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteChina
Study dates
2 May 2018to 18 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital,Second Military Medical University

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Background:

Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus, may have the potential to conquer these disadvantages.

Purpose:

  1. This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus in the treatment of PCa.
  2. This study will assess the safety of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus in the treatment of PCa.

Methods:

  1. patients recruitment
  2. transperineal maping prostate biopsy(>20 needle) guided by transrectal ultrasound(TRUS).
  3. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy;
  4. Some factors such as prostate MRI,the maping prostate biopsy(>20 needle),the histopathological outcomes analysis ect. will be performed to evaluate the efficacy of the treatment.
  5. Other factors such as the routine blood test, the routine urine test, the urinary continence ect. will be performed to evaluate the safety of the treatment.
Conditions
Prostate Cancer
Being tested
Steep Pulse Device
Keywords
focal therapy, IRE, Composite Steep-pulse Treatment Apparatus, prostate cancer, Multi-center
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Steep Pulse DeviceDevice

    Applying the steep pulse to treat the patients with Prostate cancer

Study groups in NCT03838432
Study groupRoleWhat they receive
Steep Pulse DeviceExperimentalApplying the steep pulse to treat the patients with Prostate cancer
Receives: Device: Steep Pulse Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The result of prostate maping biopsy

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

    Measured: 6 Months

  2. The result of prostate MRI

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

    Measured: 6 Months

Secondary outcomes (4)

  1. urinary incontinence

    The rate of urinary incontinence

    Measured: 6 Months

  2. urination function(IPSS scoring)

    evaluation of urination function by IPSS scoring

    Measured: 6 Months

  3. sexual function (IIEF-5 scoring)

    evaluation of sexual function by IIEF-5 scoring

    Measured: 6 Months

  4. urinary catheter retention time

    Record of urinary catheter retention time

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start2 May 2018
  3. Primary completion27 Sep 2019
  4. Study completion18 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838432
Sponsor's protocol ID
BZLC-12-1
Status last verified
Dec 2019
First submitted
18 Oct 2018
Last updated
17 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35793110

  • 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.

    PubMed 34858837

Questions about this trial

What is this clinical trial studying?

A study testing Steep Pulse Device in people with Prostate Cancer, run by Second Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The result of prostate maping biopsy (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03838432, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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