MR-guided Focal Laser Ablation of the Prostate

NCT ID: NCT02200809

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer MRI Focal Laser Ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MR-guided focal laser ablation

Group Type EXPERIMENTAL

MR-guided focal laser ablation

Intervention Type DEVICE

Interventions

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MR-guided focal laser ablation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Canisius-Wilhelmina Hospital

OTHER

Sponsor Role collaborator

Ziekenhuisgroep Twente

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jurgen Futterer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Center

Locations

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Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Site Status

Ziekenhuisgroep Twente

Hengelo, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2010/185

Identifier Type: -

Identifier Source: org_study_id

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