Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate… (NCT02766543) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
United States150 participantsStarted 2016-09-21
Plain-language 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.
Who can participate
Age range45 Years – 80 Years
SexMALE
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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
✓.1 Gleason score ≤ 3 + 4 (Part I only)
✓.2 Gleason score 3+4 (Part II only) \*now recruiting
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
What they're measuring
1
Safety Endpoint - Incidence of treatment-emergent adverse events
Timeframe: 1 year
2
Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.