Prostate Carcinoma Clinical Trial
Official title:
Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System
Verified date | January 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | March 7, 2026 |
Est. primary completion date | March 7, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male - 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | At 24 months post-treatment | |
Primary | 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. | At 12 months | |
Secondary | Biochemical failure | In the absence of a validated threshold for biochemical failure in the setting of ablative therapies, the Phoenix criteria will be adopted for the transurethral ultrasound ablation (TULSA) procedure (nadir + 2 ng/mL). Prostate-specific antigen (PSA) is measured at baseline/procedure, 3, 6, 9, 12, 15, 18, 21, and 24 months. It's measured using Scale Grade Group 1, 2, 3, and 4. | Up to 24 months | |
Secondary | Histologic failure | The proportion of patients with clinically significant disease on targeted +/- systematic biopsy at 12 months. Clinically significant disease is defined as Gleason grade group 2 or higher. It is measured using scale Grade Group 1, 2, 3, and 4. | At 12 months | |
Secondary | Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version (v)2 score for each visible lesion | These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured using Pi-Rads 1-5, 1 being most likely not cancer to 5 being very suspicious. | At 24 months post-treatment | |
Secondary | Total prostate volume | These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured. | At 24 months post-treatment | |
Secondary | Salvage-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months | |
Secondary | Biochemical failure-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months | |
Secondary | Histologic failure-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months | |
Secondary | Metastasis-free survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months | |
Secondary | Prostate cancer-specific survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months | |
Secondary | Overall survival | Will be estimated using the Kaplan-Meier method. | Up to 24 months | |
Secondary | Change in quality of life | Change from baseline in the EPIC questions 1-7 domains and in the visual analog score will be measured at baseline, 6, 12, 18, and 24 months using Scale Grade Group 1, 2, 3, and 4. | Baseline up to 24 months | |
Secondary | Change in patient-reported genitourinary function | Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4. | Baseline up to 24 months |
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