Status:
COMPLETED
MR-guided Focal Laser Ablation of the Prostate
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Canisius-Wilhelmina Hospital
Ziekenhuisgroep Twente
Conditions:
Prostate Cancer
MRI
Eligibility:
MALE
18+ years
Phase:
NA
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02200809
Start Date
July 1 2014
End Date
December 1 2019
Last Update
April 24 2020
Active Locations (3)
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1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6500 HB
2
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
3
Ziekenhuisgroep Twente
Hengelo, Overijssel, Netherlands