MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
- 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.
After completion of study treatment, patients are followed at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (MRI-guided TULSA) Patients undergo MRI-guided TULSA. |
Procedure: MRI-Guided Transurethral Ultrasound Ablation
Undergo MRI-Guided TULSA
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients free from treatment failure [At 24 months post-treatment]
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.
- Proportion of patients who maintain both urinary continence and erectile potency [At 12 months]
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.
Secondary Outcome Measures
- Biochemical failure [Up to 24 months]
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.
- Histologic failure [At 12 months]
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.
- Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version (v)2 score for each visible lesion [At 24 months post-treatment]
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.
- Total prostate volume [At 24 months post-treatment]
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.
- Salvage-free survival [Up to 24 months]
Will be estimated using the Kaplan-Meier method.
- Biochemical failure-free survival [Up to 24 months]
Will be estimated using the Kaplan-Meier method.
- Histologic failure-free survival [Up to 24 months]
Will be estimated using the Kaplan-Meier method.
- Metastasis-free survival [Up to 24 months]
Will be estimated using the Kaplan-Meier method.
- Prostate cancer-specific survival [Up to 24 months]
Will be estimated using the Kaplan-Meier method.
- Overall survival [Up to 24 months]
Will be estimated using the Kaplan-Meier method.
- Change in quality of life [Baseline up to 24 months]
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.
- Change in patient-reported genitourinary function [Baseline up to 24 months]
Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4.
Eligibility Criteria
Criteria
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 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
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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
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History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
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Artificial urinary sphincter, penile implant or intraprostatic implant
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Less than 10 years life expectancy
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Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
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Inability or unwillingness to provide informed consent
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History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David A Woodrum, Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-001336
- NCI-2022-03567
- 22-001336
- P30CA015083