Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System
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 low to 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.
Detailed 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) low to 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.
Arms & interventions
- ProcedureMRI-Guided Transurethral Ultrasound Ablation
Undergo MRI-Guided TULSA
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureDigital Rectal Examination
Undergo DRE
- ProcedureCystoscopy
Undergo cystoscopy
- ProcedureBiopsy
Undergo biopsy
- ProcedureBone Scan
Undergo bone scan
- ProcedurePSMA PET Scan
Undergo PSMA PET
- ProcedureMultiparametric Magnetic Resonance Imaging
Undergo mpMRI
Outcome measures
Primary
Proportion of patients free from treatment failure
Failure is defined as: delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy); or metastatic disease; or prostate cancer-specific death.
Time frame: At 24 months post-treatment
Proportion of patients who maintain both urinary continence and erectile potency
Continence is defined as 'pad-free' (0 pads/day), and potency is defined as erection firmness sufficient for penetration (Expanded Prostate Cancer Index Composite \[EPIC\]). Two-sided, 95% Pearson-Clopper confidence interval (CI) will be calculated for each intervention arm separately, and the difference in safety outcomes, along with exact 95% two-sided CI will be calculated.
Time frame: At 12 months
Secondary
Biochemical failure
Time frame: Up to 24 months
Histologic failure
Time frame: At 12 months
Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion
Time frame: At 24 months post-treatment
Total prostate volume
Time frame: At 24 months post-treatment
Salvage-free survival
Time frame: Up to 24 months
Biochemical failure-free survival
Time frame: Up to 24 months
Histologic failure-free survival
Time frame: Up to 24 months
Metastasis-free survival
Time frame: Up to 24 months
Prostate cancer-specific survival
Time frame: Up to 24 months
Overall survival
Time frame: Up to 24 months
Change in quality of life
Time frame: Baseline up to 24 months
Change in patient-reported genitourinary function
Time frame: Baseline up to 24 months
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905