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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01726894
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven prostate cancer, Gleason Score \</=7
* An anterior visible lesion on mpMRI, that is accessible to IRE treatment
* Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones)
* Absence of clinically significant disease outside of the planned treatment zone, from histopathology and/or mpMRI findings
* Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines
* Serum PSA \</=15 ng/ml
* Life expectancy of \>/= 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
* 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 non-visible tumour on mpMRI
* Men with an inability to tolerate a transrectal ultrasound
* Men with latex allergies
* Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individual cases)
* Men who have had previous IRE, 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 6 months. These patients may be included within the trial if deferred from consenting 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 GFR of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01726894
Study Brief:
Protocol Section:
NCT01726894