MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:

Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438563
• Other study ID #: 22-001336
• Secondary ID: NCI-2022-03567
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: March 7, 2026

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8

Intervention

Procedure:
• MRI-Guided Transurethral Ultrasound Ablation
Undergo MRI-Guided TULSA

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Digital Rectal Examination
Undergo DRE
• Cystoscopy
Undergo cystoscopy
• Biopsy
Undergo biopsy
• Bone Scan
Undergo bone scan
• PSMA PET Scan
Undergo PSMA PET
• Multiparametric Magnetic Resonance Imaging
Undergo mpMRI

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials