NCT02200809

Completed

MR-guided Focal Laser Ablation of the Prostate

Radboud University Medical Center Source

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Other study identifiers

Sponsor study identifier

2010/185

Study Type

interventional

Estimated enrollment

20

Locations

1 country

Sites

3

Timeline

Study Start

July 2014

Actual (reported)

Primary Completion

December 2019

Actual (reported)

Study Completion

December 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 20 participants
Study completion date: December 2019
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2014
Actual (reported)
First Submitted
July 21, 2014
Actual (reported)
First Posted
July 25, 2014
Actual (reported)
Primary Completion
December 2019
Actual (reported)
Study Completion
December 2019
Actual (reported)

Last Updated: April 24, 2020
Status Verified: April 2018
Last Update Submitted: April 23, 2020

Conditions

Focal Laser Ablation MRI Prostate Cancer

Keywords

MR-guided therapyFocal laser ablationProstate cancer

Outcome Measures

Primary Outcomes (1)

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.
36 months.

Study Arms (1)

MR-guided focal laser ablation

EXPERIMENTAL

Device: MR-guided focal laser ablation

Interventions

MR-guided focal laser ablationDevice

MR-guided focal laser ablation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Newly diagnosed and biopsy proven prostate cancer
Intermediate risk patients (PSA \<= 20 ng/mL, Gleason ≤ 7, T2b)

Sponsors & Collaborators

Canisius-Wilhelmina Hospital
Othercollaborator
Ziekenhuisgroep Twente
Othercollaborator
Radboud University Medical Center

Study Sites (3)

Radboud University Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Ziekenhuisgroep Twente

Hengelo, Overijssel, Netherlands

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

Jurgen Futterer, MD, PhD
Radboud University Nijmegen Medical Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 25, 2014

Study Start

July 2014

Actual (reported)

Primary Completion

December 2019

Actual (reported)

NCT03011606

Robotic Surgery After Focal Ablation Therapy

Not ApplicableCompleted

NCT03634579

MRI Guided Prostate Cancer Focal Laser Ablation

Not ApplicableTerminated

NCT06223295

Effectiveness of Focal Therapy in Men With Prostate Cancer

Not ApplicableRecruiting

NCT00588679

Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Not ApplicableCompleted

NCT03253458

Focal Prostate Imaging With CLE and OCT

Not ApplicableUnknown

NCT01726894

Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

Not ApplicableUnknown

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Otherlead

Study Completion

December 2019

Actual (reported)

Last Updated

April 24, 2020

Record last verified: 2018-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02200809
Data provider: ClinicalTrials.gov
Source updated: 2020-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:23 UTC

Locations

NL(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

MR-guided focal laser ablation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations