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

Not Applicable

Recruiting

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

Interventions: Procedure: MRI-Guided Transurethral Ultrasound Ablation
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Digital Rectal Examination
Procedure: Cystoscopy
Procedure: Biopsy
Procedure: Bone Scan
Procedure: PSMA PET Scan
Procedure: Multiparametric Magnetic Resonance Imaging

Registration Number: NCT05438563

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: RECRUITING

Sex: Male

Target Recruitment: 25

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (MRI-guided TULSA)	Cystoscopy	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	PSMA PET Scan	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	Bone Scan	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	Quality-of-Life Assessment	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	MRI-Guided Transurethral Ultrasound Ablation	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	Digital Rectal Examination	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	Biopsy	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	Multiparametric Magnetic Resonance Imaging	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment (MRI-guided TULSA)	Questionnaire Administration	Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.

Primary Outcome Measures

Name	Time	Method
Proportion of patients free from treatment failure	At 24 months post-treatment	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.
Proportion of patients who maintain both urinary continence and erectile potency	At 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Biochemical failure	Up to 24 months	In the absence of a validated threshold for biochemical failure in the setting of ablative therapies, the Phoenix criteria will be adopted for the transurethral ultrasound ablation (TULSA) procedure (nadir + 2 ng/mL). Prostate-specific antigen (PSA) is measured at baseline/procedure, 3, 6, 9, 12, 15, 18, 21, and 24 months. It's measured using Scale Grade Group 1, 2, 3, and 4.
Total prostate volume	At 24 months post-treatment	These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured.
Histologic failure	At 12 months	The proportion of patients with clinically significant disease on targeted +/- systematic biopsy at 12 months. Clinically significant disease is defined as Gleason grade group 2 or higher. It is measured using scale Grade Group 1, 2, 3, and 4.
Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version (v)2 score for each visible lesion	At 24 months post-treatment	These data will also be collected at 24 months post-initial treatment, for patients who receive repeat TULSA procedure. Findings from for-cause mpMRI will also be captured using Pi-Rads 1-5, 1 being most likely not cancer to 5 being very suspicious.
Prostate cancer-specific survival	Up to 24 months	Will be estimated using the Kaplan-Meier method.
Change in quality of life	Baseline up to 24 months	Change from baseline in the EPIC questions 1-7 domains and in the visual analog score will be measured at baseline, 6, 12, 18, and 24 months using Scale Grade Group 1, 2, 3, and 4.
Salvage-free survival	Up to 24 months	Will be estimated using the Kaplan-Meier method.
Biochemical failure-free survival	Up to 24 months	Will be estimated using the Kaplan-Meier method.
Histologic failure-free survival	Up to 24 months	Will be estimated using the Kaplan-Meier method.
Change in patient-reported genitourinary function	Baseline up to 24 months	Change from baseline in the EPIC questions 8-21 will be measured using Scale Grade Group 1, 2, 3, and 4.
Metastasis-free survival	Up to 24 months	Will be estimated using the Kaplan-Meier method.
Overall survival	Up to 24 months	Will be estimated using the Kaplan-Meier method.

Trial Locations

Locations (1): Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States

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

Recruitment & Eligibility

Study & Design

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