Prostate Cancer Clinical Trial
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer
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. TULSA ablation is a minimally invasive procedure that uses targeted ultrasound device to deliver high-frequency, electric current to kill cancer cells by heating them. The TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
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.
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.
Patients undergo MRI-guided TULSA.
After completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Age 45-80 years, with > 10 years life expectancy
Biopsy-confirmed, NCCN (favorable Gleason grade [GG2] 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 PI-RADS v2 category >= 3 lesion). Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
PSA =< 20 ng/mL reported within 3 months of baseline
Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
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
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