MR-guided Focal Laser Ablation of the Prostate

April 23, 2020 updated by: Radboud University Medical Center
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud university medical center
      • Nijmegen, Gelderland, Netherlands
        • Canisius Wilhelmina Hospital
    • Overijssel
      • Hengelo, Overijssel, Netherlands
        • Ziekenhuisgroep Twente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Newly diagnosed and biopsy proven prostate cancer
  • Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b)
  • No previous treatment for prostate cancer
  • Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
  • Signed informed consent by patient
  • Age 18 years or older
  • Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)

Exclusion Criteria:

  • Impossibility to obtain a valid informed consent
  • Patients unable to undergo MR imaging, including those with contra-indications
  • Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
  • Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
  • Patients with evidence for nodal or metastatic disease
  • Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MR-guided focal laser ablation
Device: MR-guided focal laser ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 36 months.
The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.
36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Ziekenhuisgroep Twente
Canisius-Wilhelmina Hospital

Investigators

  • Principal Investigator: Jurgen Futterer, MD, PhD, Radboud University Nijmegen Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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