Back to resultsMR-guided Focal Laser Ablation of the Prostate
Primary Purpose
Prostate Cancer, MRI, Focal Laser Ablation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MR-guided focal laser ablation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring MR-guided therapy, Focal laser ablation, Prostate cancer
Eligibility Criteria
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
Sites / Locations
- Radboud University Medical Center
- Canisius Wilhelmina Hospital
- Ziekenhuisgroep Twente
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR-guided focal laser ablation
Arm Description
Outcomes
Primary Outcome Measures
Disease free survival
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02200809
First Posted
July 21, 2014
Last Updated
April 23, 2020
Sponsor
Radboud University Medical Center
Collaborators
Canisius-Wilhelmina Hospital, Ziekenhuisgroep Twente
1. Study Identification
Unique Protocol Identification Number
NCT02200809
Brief Title
MR-guided Focal Laser Ablation of the Prostate
Official Title
MR-guided Focal Laser Ablation of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Canisius-Wilhelmina Hospital, Ziekenhuisgroep Twente
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, MRI, Focal Laser Ablation
Keywords
MR-guided therapy, Focal laser ablation, Prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR-guided focal laser ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MR-guided focal laser ablation
Primary Outcome Measure Information:
Title
Disease free survival
Description
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.
Time Frame
36 months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurgen Futterer, MD, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Canisius Wilhelmina Hospital
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente
City
Hengelo
State/Province
Overijssel
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
MR-guided Focal Laser Ablation of the Prostate
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