Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02294903
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT02294903
Study Brief:
Protocol Section:
NCT02294903