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

Mayo Clinic

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05438563

NCI-2022-03567 (Registry Identifier)

22-001336 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment (MRI-guided TULSA)

Experimental group

Description:

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

Treatment:

Procedure: Biopsy

Procedure: Digital Rectal Examination

Other: Questionnaire Administration

Procedure: Multiparametric Magnetic Resonance Imaging

Procedure: PSMA PET Scan

Procedure: Cystoscopy

Procedure: MRI-Guided Transurethral Ultrasound Ablation

Procedure: Bone Scan