Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

361 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2025-04-30

Brief Summary

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The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline. Secondary objectives are to establish which indications lead to treatment with IRE Nanoknife® setting and safety assessment measured by number of complications and adverse events.

Detailed Description

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This is an international prospective observational multi-center study in which data on consecutive patients for 5 years with prostate cancer who undergo IRE are collected. Data from each patient will be collected at participating centers over a 5-year period. Patients' data at baseline visit (pre-IRE), peri-operative data and follow up for 5 years will be recorded. Follow up data will be collected according to the following schedule:

1 - 2 weeks after surgery

1. st year: every 3 months
2. nd year: every three months
3. rd year: every 6 months
4. th and 5th year: once a year. Data from participating centers will be collected through electronic Case Report Forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office. The data collection or patient participation in this study does not interfere with the choice of treatment, sample collection, procedures and the treatment itself, which should entirely follow standard hospital practices, including the follow up.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Is diagnosed with histologically confirmed prostate cancer
* Is scheduled for IRE Nanoknife®
* Has signed informed consent form

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean de la Rosette

Role: STUDY_CHAIR

Clinical Research Office of the Endourological Society

Locations

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AMC University Hospital

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Registry IRE Nanoknife®

Identifier Type: -

Identifier Source: org_study_id