Recruiting

MRI-guided Ablation

Sponsor:

Mayo Clinic

Code:

NCT05438563

Conditions

Prostate Carcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI-Guided Transurethral Ultrasound Ablation

Questionnaire Administration

Digital Rectal Examination

Cystoscopy

Biopsy

Study Details

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

Study ID

NCT05438563

Start date

Apr 6, 2022

Status verified date

Jul, 2026

Completion date

Dec 7, 2028

Anticipated

Primary completion date

Jul 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

MRI-Guided Transurethral Ultrasound Ablation

Undergo MRI-Guided TULSA

Questionnaire Administration

Ancillary studies

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

Primary outcome measure

  • Proportion of patients free from treatment failure [ Time Frame: At 24 months post-treatment ]
  • Proportion of patients who maintain both urinary continence and erectile potency [ Time Frame: At 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trial Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

David A. Woodrum, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-22.