Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Profound Medical Inc.
- Enrollment
- 150
- Locations
- 14
- Primary Endpoint
- Safety Endpoint - Incidence of treatment-emergent adverse events
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Detailed Description
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue. The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland. It provides advantages of a non-invasive procedure with short treatment times.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male, age 45 to 80 years
- •Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment (or at the discretion of PI and approval by the Sponsor).
- •Clinical stage ≤ T2b
- •4.1 Gleason score ≤ 3 + 4 (Part I only)
- •4.2 Gleason score 3+4 (Part II only) \*now recruiting
- •PSA ≤ 15 ng/ml
- •Eligible for MRI \[Form GCP-10131\]
- •Eligible for general anesthesia (ASA category ≤ 3)
- •Prostate volume ≤ 90 cc, on Baseline MRI
- •Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
Exclusion Criteria
- •Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
- •Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
- •Prior definitive treatment of prostate cancer
- •Prior transurethral resection of the prostate (TURP)
- •Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
- •Prostate calcifications \> 1 cm in largest diameter, on Baseline Ultrasound
- •Cysts \> 1 cm in largest diameter, on Baseline MRI
- •Bleeding disorder (INR \> ULN and PTT \> ULN)
- •Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
- •Acute unresolved Urinary Tract Infection (UTI)
Outcomes
Primary Outcomes
Safety Endpoint - Incidence of treatment-emergent adverse events
Time Frame: 1 year
Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
Time Frame: 1 year
Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
Secondary Outcomes
- Erection Firmness Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- Prostate Volume Endpoint(1 year)
- CE-MRI Endpoint(Immediately after treatment)
- PSA Nadir Endpoint(1 year)
- mpMRI Endpoint(1 year)
- Erectile Dysfunction Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- IPSS Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- IIEF Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- EPIC Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- Targeting Accuracy Endpoint(During treatment)
- Urinary Incontinence Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- PSA Stability Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- Prostate Biopsy Endpoint(1 year)