NCT02255890

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 361 (estimated)
• Sponsor: Clinical Research Office of the Endourological Society · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Timeline

• Start date: 2014-11-01
• Primary completion: 2020-06-01
• Completion: 2025-04-01
• First posted: 2014-10-03
• Last updated: 2020-12-14

Locations

1 site across 1 country: Netherlands