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RecruitingInterventional

Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System

NCT ID: NCT05438563Sponsor: Mayo ClinicLast updated: 2025-09-09

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.

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) low to 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.

Arms & interventions

  • ProcedureMRI-Guided Transurethral Ultrasound Ablation

    Undergo MRI-Guided TULSA

  • OtherQuestionnaire Administration

    Ancillary studies

  • ProcedureDigital Rectal Examination

    Undergo DRE

  • ProcedureCystoscopy

    Undergo cystoscopy

  • ProcedureBiopsy

    Undergo biopsy

  • ProcedureBone Scan

    Undergo bone scan

  • ProcedurePSMA PET Scan

    Undergo PSMA PET

  • ProcedureMultiparametric Magnetic Resonance Imaging

    Undergo mpMRI

Outcome measures

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.

    Time frame: 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.

    Time frame: At 12 months

Secondary

  • Biochemical failure

    Time frame: Up to 24 months

  • Histologic failure

    Time frame: At 12 months

  • Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion

    Time frame: At 24 months post-treatment

  • Total prostate volume

    Time frame: At 24 months post-treatment

  • Salvage-free survival

    Time frame: Up to 24 months

  • Biochemical failure-free survival

    Time frame: Up to 24 months

  • Histologic failure-free survival

    Time frame: Up to 24 months

  • Metastasis-free survival

    Time frame: Up to 24 months

  • Prostate cancer-specific survival

    Time frame: Up to 24 months

  • Overall survival

    Time frame: Up to 24 months

  • Change in quality of life

    Time frame: Baseline up to 24 months

  • Change in patient-reported genitourinary function

    Time frame: Baseline up to 24 months

Eligibility criteria

Sex: MaleAge: 45 Years to 80 YearsHealthy volunteers: No
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 locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trial Referral Office · Contact
David A. Woodrum, MD, PhD · Principal Investigator