MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-80
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MRI-Guided Transurethral Ultrasound Ablation
Procedure/SurgeryUndergo MRI-Guided TULSA
Questionnaire Administration
Other interventionAncillary studies
Digital Rectal Examination
Procedure/SurgeryUndergo DRE
Cystoscopy
Procedure/SurgeryUndergo cystoscopy
Biopsy
Procedure/SurgeryUndergo biopsy
Bone Scan
Procedure/SurgeryUndergo bone scan
PSMA PET Scan
Procedure/SurgeryUndergo PSMA PET
Multiparametric Magnetic Resonance Imaging
Procedure/SurgeryUndergo mpMRI
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Treatment (MRI-guided TULSA)Experimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
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-treatment2
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 monthsSecondary outcomes
1
Biochemical failure
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.
Time frame
Up to 24 months2
Histologic failure
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.
Time frame
At 12 months3
Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion
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.
Time frame
At 24 months post-treatment4
Total prostate volume
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.
Time frame
At 24 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov