NCT02255890

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

5.6 years

First QC Date

September 26, 2014

Last Update Submit

December 11, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population comprises those patients diagnosed with histologically confirmed prostate cancer and are scheduled for treatment with IRE Nanoknife®.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMC University Hospital

Amsterdam, 1105AZ, Netherlands

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jean de la Rosette

    Clinical Research Office of the Endourological Society

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 3, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2020

Study Completion

April 1, 2025

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

NL(1)