Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MR-guided focal laser ablation
MR-guided focal laser ablation
Interventions
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MR-guided focal laser ablation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Canisius-Wilhelmina Hospital
OTHER
Ziekenhuisgroep Twente
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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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
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Ziekenhuisgroep Twente
Hengelo, Overijssel, Netherlands
Countries
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Other Identifiers
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2010/185
Identifier Type: -
Identifier Source: org_study_id
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