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

Not Applicable

Recruiting

• Conditions: Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Prostate Carcinoma

• Registration Number: NCT05438563
• Lead Sponsor: Mayo Clinic

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. 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) 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.

Study Timeline

• Study Start: 2022-04-06
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-03-07
• Study Completion: 2027-03-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States