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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255890
Recruitment Status : Active, not recruiting
First Posted : October 3, 2014
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society

Study Description
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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.

Condition or disease
Prostate Cancer

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 361 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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.
Actual Study Start Date : November 2014
Actual Primary Completion Date : June 2020
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. to establish which indications lead to treatment with IRE Nanoknife® setting [ Time Frame: 5 years ]
  2. safety assessment measured by number of complications and adverse events [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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®.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255890


Locations
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Netherlands
AMC University Hospital
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Clinical Research Office of the Endourological Society
Investigators
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Study Chair: Jean de la Rosette Clinical Research Office of the Endourological Society
More Information
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Additional Information:

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Responsible Party: Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier: NCT02255890    
Other Study ID Numbers: Registry IRE Nanoknife®
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases