Overview
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.
Description
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
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