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

Prostate Cancer Clinical Trial

Official title:

Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device; A Multi-Center, International Registry to Evaluate the Treatment of Prostate Cancer in Terms of Recurrence, Functional Outcomes and Safety.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02255890
• Other study ID #: Registry IRE Nanoknife®
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: April 2025

Study information

• Verified date: December 2020
• Source: Clinical Research Office of the Endourological Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 361
• Est. completion date: April 2025
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Netherlands	AMC University Hospital	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Office of the Endourological Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to establish which indications lead to treatment with IRE Nanoknife® setting		5 years
Secondary	safety assessment measured by number of complications and adverse events		5 years

External Links

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