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

Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Biopsy; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: MRI-Guided Transurethral Ultrasound Ablation; Procedure: Cystoscopy; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: Digital Rectal Examination

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trial Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: David A. Woodrum, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (MRI-guided TULSA); Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Biopsy; Undergo biopsy; Other Names: Bx; Procedure: Multiparametric Magnetic Resonance Imaging; Undergo mpMRI; Other Names: Multiparametric MRI; MP-MRI; mpMRI; Multi-parametric MRI; Procedure: MRI-Guided Transurethral Ultrasound Ablation; Undergo MRI-Guided TULSA; Other Names: MRI-TULSA; Procedure: Cystoscopy; Undergo cystoscopy; Other Names: CS; Procedure: Bone Scan; Undergo bone scan; Other Names: Bone Scintigraphy; Procedure: PSMA PET Scan; Undergo PSMA PET; Other Names: PSMA PET; Prostate-specific Membrane Antigen PET; PSMA-Positron emission tomography; Procedure: Digital Rectal Examination; Undergo DRE; Other Names: DRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Salvage-free survival	Will be estimated using the Kaplan-Meier method.	Up to 24 months
Biochemical failure-free survival	Will be estimated using the Kaplan-Meier method.	Up to 24 months
Histologic failure-free survival	Will be estimated using the Kaplan-Meier method.	Up to 24 months
Metastasis-free survival	Will be estimated using the Kaplan-Meier method.	Up to 24 months
Prostate cancer-specific survival	Will be estimated using the Kaplan-Meier method.	Up to 24 months
Overall survival	Will be estimated using the Kaplan-Meier method.	Up to 24 months
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David A Woodrum, M.D., Ph.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Estimated): March 7, 2025
• Study Completion (Estimated): March 7, 2026

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 22-001336 (Mayo Clinic in Rochester); NCI-2022-03567 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No