Status:
UNKNOWN
Focal Prostate Radiofrequency Ablation
Lead Sponsor:
Trod Medical N.V.
Conditions:
Prostate Cancer
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
To assess the early histological outcomes of tissue ablation, adverse events and genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar device to treat localized pro...
Detailed Description
The study aims to assess the ability of focal therapy using coiled bipolar radiofrequency device to ablate a pre-defined target tissue zone as well as assess side-effects. The medical device has a coi...
Eligibility Criteria
Inclusion
- Histologically proven prostate cancer
- A visible lesion on multiparametric Magnetic Resonance Imaging (mpMRI), that is accessible to a treatment based on radiofrequency bipolar electrodes
- Transperineal prostate biopsies (template mapping and/or targeted) correlating with clinically significant lesion in the area of the Magnetic Resonance (MR)-visible lesion
- Absence of clinically significant histological disease outside of the planned treatment zone
- Radiological stage T1-T3aN0M0 disease, as determined by local guidelines
- Serum prostate-specific antigen (serum PSA) \</=15ng/ml within 3 months of screening visit
- Life expectancy of more than 10 years
- Signed informed consent by patient
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Exclusion
- Men who have had previous radiation therapy to the pelvis
- Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- Men with a tumour not visible on mpMRI
- Men with an inability to tolerate a transrectal ultrasound (TRUS)
- Men allergic to latex
- Men who have undergone prior significant rectal surgery preventing insertion of the transrectal ultrasound probe (decided on the type of surgery in individual cases)
- Men who have had previous electroporation, radiofrequency ablation, High Intensity Focused Ultrasound (HIFU), cryosurgery, thermal or microwave therapy to the prostate
- Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within the prior 6 months. These patients may be included within the trial if deferred from consent and screening until at least 6 months following the TURP
- Men not fit for major surgery as assessed by a Consultant Anaesthetist
- Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
- Presence of metal implants/stents in the urethra
- Men with renal impairment with a Glomerular Filtration Rate (GFR) of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02294903
Start Date
March 1 2015
End Date
May 30 2018
Last Update
April 24 2018
Active Locations (1)
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1
University College London Hospitals
London, United Kingdom, NW1 2PS