Clinical trial NCT05438563: MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer
Official title: Focal Prostate Ablation for Intermediate Grade Cancer Utilizing TULSA Profound System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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) 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Proportion of patients free from treatment failure
timeFrame: At 24 months post-treatment
measure: Proportion of patients who maintain both urinary continence and erectile potency
timeFrame: At 12 months
Secondary outcomes:
measure: Biochemical failure
timeFrame: Up to 24 months
measure: Histologic failure
timeFrame: At 12 months
measure: Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion
timeFrame: At 24 months post-treatment
measure: Total prostate volume
timeFrame: At 24 months post-treatment
measure: Salvage-free survival
timeFrame: Up to 24 months
measure: Biochemical failure-free survival
timeFrame: Up to 24 months
measure: Histologic failure-free survival
timeFrame: Up to 24 months
measure: Metastasis-free survival
timeFrame: Up to 24 months
measure: Prostate cancer-specific survival
timeFrame: Up to 24 months
measure: Overall survival
timeFrame: Up to 24 months
measure: Change in quality of life
timeFrame: Baseline up to 24 months
measure: Change in patient-reported genitourinary function
timeFrame: Baseline up to 24 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: David A Woodrum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: