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

NCT05438563 | Recruiting

• 2 other identifiers: 22-001336NCI-2022-03567
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 low to 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.

Conditions

Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Biochemical failure

  Up to 24 months

• Histologic failure

  At 12 months

• 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

• Total prostate volume

  At 24 months post-treatment

• Salvage-free survival

  Up to 24 months

Study Arms (1)

Treatment (MRI-guided TULSA)

EXPERIMENTAL

Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.

Procedure: MRI-Guided Transurethral Ultrasound Ablation; Other: Questionnaire Administration; Procedure: Digital Rectal Examination; Procedure: Cystoscopy; Procedure: Biopsy; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: Multiparametric Magnetic Resonance Imaging

Interventions

MRI-Guided Transurethral Ultrasound Ablation PROCEDURE

Undergo MRI-Guided TULSA

Also known as: MRI-TULSA

Treatment (MRI-guided TULSA)

Questionnaire Administration OTHER

Ancillary studies

Treatment (MRI-guided TULSA)

Digital Rectal Examination PROCEDURE

Undergo DRE

Also known as: DRE

Treatment (MRI-guided TULSA)

Cystoscopy PROCEDURE

Undergo cystoscopy

Also known as: CS

Treatment (MRI-guided TULSA)

Biopsy PROCEDURE

Undergo biopsy

Also known as: Bx, BIOPSY_TYPE

Treatment (MRI-guided TULSA)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Treatment (MRI-guided TULSA)

PSMA PET Scan PROCEDURE

Undergo PSMA PET

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Treatment (MRI-guided TULSA)

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo mpMRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Treatment (MRI-guided TULSA)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age 45-80 years, with \> 10 years life expectancy
• Biopsy-confirmed, NCCN \[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\] intermediate-risk prostate cancer
• Stage =\< T2c, N0, M0
• International Society of Urological Pathology (ISUP) grade group 1, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cystoscopy; Biopsy; Glutamate Carboxypeptidase II

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• David A Woodrum, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 30, 2022
• Study Start: April 6, 2022
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): March 7, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)