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

Clinical Research Office of the Endourological Society

Status

Active, not recruiting

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02255890

Registry IRE Nanoknife®

Details and patient eligibility

About

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.

Full 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

st year: every 3 months
nd year: every three months
rd year: every 6 months
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.

Enrollment

361 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria