MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
NCT ID: NCT05438563
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-04-06
2027-03-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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David A. Woodrum
Principal Investigator
Principal Investigators
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David A Woodrum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-03567
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-001336
Identifier Type: -
Identifier Source: org_study_id
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