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

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT02255890
• Lead Sponsor: Clinical Research Office of the Endourological Society

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-03
• Study Start: 2014-11
• Primary Completion: 2020-06
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 361

Inclusion Criteria

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

Exclusion Criteria

• No specific exclusion criteria are defined.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	10 years

Secondary Outcome Measures

Name	Time	Method
to establish which indications lead to treatment with IRE Nanoknife® setting	5 years
safety assessment measured by number of complications and adverse events	5 years

Trial Locations

Locations (1)

AMC University Hospital; 🇳🇱 Amsterdam, Netherlands