Clinical trial NCT02255890: Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Clinical Research Office of the Endourological Society
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 361
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises those patients diagnosed with histologically confirmed prostate cancer and are scheduled for treatment with IRE Nanoknife®.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 10 years
Secondary outcomes:
measure: to establish which indications lead to treatment with IRE Nanoknife® setting
timeFrame: 5 years
measure: safety assessment measured by number of complications and adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC University Hospital
Study officials:
affiliation: Clinical Research Office of the Endourological Society
name: Jean de la Rosette
role: STUDY_CHAIR
References: