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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT02265159
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
* Template biopsy:
* unilateral disease (Gleason ≤4+3)
* bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of \>50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and \<50% of biopsy cores positive on any one side but with dominant disease burden on one side
* Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
* Serum PSA ≤15
* Life expectancy of ≥10 years
* Signed informed consent by patient
* An understanding of the German language sufficient to understand written and verbal information about the trial and consent process
Exclusion Criteria:
* 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 an inability to tolerate a transrectal ultrasound
* Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
* Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
* Men who have had previous 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
* Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
* Men with renal impairment with a glomerular filtration rate of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
99 Years
Study:
NCT02265159
Study Brief:
Protocol Section:
NCT02265159