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.
- Clements University Hospital
Yair Lotan, M.D.
This study is a prospective, multi-center, single arm clinical trial evaluating the TuLSa-PRo MRi-guided transurethral ultrasound prostate ablation device for prostate ablation in patients with localized, organ-confined prostate cancer.
Men diagnosed with biopsy-proven, organ-confined, low- to intermediate-risk prostate cancer will be eligible for participation in this study, provided they have not received prior treatment of their prostate cancer. Subjects must satisfy all inclusion and none of the exclusion criteria, and provide a signed written informed consent prior to their participation in the study. all subjects will undergo prostate ablation with the TuLSa-PRo device and then will be followed clinically to evaluate the study primary and secondary endpoints.The primary objective of this study is to further evaluate the safety and effectiveness of the MRi-guided TuLSa-PRo device intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer. There are multiple secondary objectives of this study designed to examine in more detail the safety and effectiveness of the TuLSa-PRo device, as well as its impact on patient quality of life. additional secondary imaging endpoints evaluate the spatial accuracy and precision of prostate ablation using TuSLa-PRo device, as well as changes observed on diagnostic prostate MRi.
each subject will participate in eleven patient visits, categorized into four study periods: 1) Pre-Study Baseline, 2) MRi-TuLSa Procedure, 3) 12-month Follow-up, and 4) Long-Term Follow-up. Subjects will have completed the study once they have completed their 5-year follow-up visit. Subjects who have undergone the prostate ablation treatment and who withdraw from the study prior to the 12-month follow-up will be asked to complete the prostate MRi scan and biopsy.
The number of patients to be enrolled into the clinical study is 110. once subject enrollment begins, it is expected that at least twenty procedures will be conducted per month using the TuLSa-PRo. The primary endpoints of the study are intended to be completed 12 months after the last patient has undergone the prostate ablation treatment. The study will be complete once the 110th subject has undergone treatment and completes the 5-year follow-up visit. The study primary endpoints will be complete once the 110th subject has undergone treatment and completes the 12-month follow-up visit. a formal interim analysis of the secondary endpoints will be performed once the 110th subject has undergone prostate ablation treatment and completes the 12-month follow-up visit. an independent steering committee (Data and Safety Monitoring Committee, DSMC) will be established to review the study outcome.
1. Male, age 45 to 80 years
2. 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 approved by the Sponsor
3. Clinical stage <= T2b
4. Gleason score <= 3 + 4
5. PSA <= 15 ng/ml
6. Eligible for MRI [Form GCP-10131]
7. Eligible for general anesthesia (ASA category <= 3)
8. Prostate volume <= 90 cc, on Baseline MRI
9. Prostate size <= 5.0 cm in sagittal length, and <= 6.0 cm in axial diameter, on Baseline MRI
10. Life expectancy >= 10 years