mri-guided transurethral urethral ultrasound ablation for the treatment of intermediate grade prostate cancer

Conditions: Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8

Summary: this clinical trial tests whether the magnetic resonance imaging (mri)-guided transurethral ultrasound ablation (tulsa) procedure is safe and effective in treating patients with intermediate grade prostate cancer. mri-guided tulsa ablation is a minimally invasive procedure that uses an ultrasound device guided by mri imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. the mri-guided tulsa procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.

primary objective: i. to perform the tulsa procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, national comprehensive cancer network (nccn) intermediate-risk prostate cancer. secondary objective: i. to assess patient-reported metrics for quality of life (qol). ii. to assess return to normal activity. iii. compare economic benefit as noted from expanded prostate cancer index composite (epic) questionnaire. outline: patients undergo mri-guided tulsa. patients may also undergo digital rectal exam (dre), cystoscopy, biopsy, bone scan, prostate specific membrane antigen (psma) positron emission tomography (pet), and/or multiparametric mri (mpmri) at screening. after completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months.

Eligibility criteria:
inclusion criteria: * male * age 45-80 years, with \> 10 years life expectancy * biopsy-confirmed, nccn \[favorable gleason grade (gg) 2 and unfavorable gg3\] intermediate-risk prostate cancer * stage =\< t2c, n0, m0 * international society of urological pathology (isup) grade group 2 or 3 disease on transrectal ultrasonography (trus)-guided biopsy (minimum 8 cores, combination of systematic and mri fusion-guided) or in-bore biopsy \[minimum 3 cores from each prostate imaging-reporting and data system (pi-rads) version (v)2 category \>= 3 lesion\]. biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline * prostate specific antigen (psa) =\< 20 ng/ml reported within 3 months of baseline * treatment naive * planned ablation volume \< 3.0 cm axial radius from the urethra on mpmri acquired within 6 months of baseline exclusion criteria: * inability to undergo mri or general anaesthesia * suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra * prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (ct) * criteria subject to additional review and approval by sponsor. alternatively, prospective trus to query calcifications or susceptibility-weighted mri if available may be used to assess calcification. imaging for calcification screening must be dated within 1 year of baseline visit * unresolved urinary tract infection or prostatitis * history of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder * artificial urinary sphincter, penile implant or intraprostatic implant * less than 10 years life expectancy * patients who are otherwise not deemed candidates for radical prostatectomy (rp) * inability or unwillingness to provide informed consent * history of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices