MR-guided Focal Laser Ablation of the Prostate
1 other identifier
interventional
20
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Jul 2014
Typical duration for not_applicable prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 24, 2020
April 1, 2018
5.4 years
July 21, 2014
April 23, 2020
Conditions
Keywords
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
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
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.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Canisius-Wilhelmina Hospitalcollaborator
- Ziekenhuisgroep Twentecollaborator
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jurgen Futterer, MD, PhD
Radboud University Nijmegen Medical Center
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 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 24, 2020
Record last verified: 2018-04