Condition: Prostate Cancer, Prostate Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06223295

Sponsor: Radboud University Medical Center

Eligibility:

• Age: minimum 45 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3)
• PSA level of ≤ 20 ng/ml
• Clinical stage ≤ T2b disease
• Life expectancy of ≥ 10 years
• Men with a prostate size ≤ 5 cm in sagittal length and ≤ 6 cm in axial length
• Fit, eligible, and normally destined for radical surgery or radiotherapy
• No concomitant cancer
• No previous treatment of their prostate
• An understanding of the Dutch language sufficient to receive written and verbal information about the trial, its consent process and the study questionnaires

Exclusion Criteria:

• Unfit for general anesthesia or radical surgery
• Low volume low-risk disease (≤4mm Gleason score of ≤ 6 / ISUP grade 1)
• High-risk disease (Gleason score of ≥ 8 / ISUP grade >3)
• Clinical T3 disease (extracapsular PCa)
• Men who have received previous active therapy for PCa.
• Men with evidence of extraprostatic disease.
• Men with an inability to tolerate a transrectal ultrasound.
• Cardiac pacemaker
• Metal implants/stents in the urethra or prostate.
• ASA ≥4
• Prostatic calcification/cysts that interfere with effective delivery of TULSA/HIFU based on MRCT.
• Men with renal impairment and a glomerular filtration rate (GFR) of < 30 ml/minute/1.73 m2.
• Unable to give consent to participate in the trial, as judged by the attending clinicians

View trial on ClinicalTrials.gov