這是一項多中心、前瞻性、隨機臨床試驗，旨在評估 Aquablation 治療用於低風險至中風險至高風險局部前列腺癌男性的安全性及療效，該等男性為前列腺切除術的適合人選或已選擇接受前列腺切除術。參加者將被隨機分配接受 Aquablation 治療或根治性前列腺切除術，並隨訪長達 10 年。
適應症：Localized Prostate Cancer
收案條件
納入條件
- Biological male with age ≥ 45 years at the time of consent
- Biopsy positive Grade Group 1-3 prostate cancer
- Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
- Clinical Stage ≤ T2c
- PSA ≤ 20 ng/ml
- Prostate volume ≥25 ml
排除條件
- Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy.
- Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
- Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
- Patient is unwilling to accept a blood transfusion if required.
- Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:
- a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease).
- \. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated.
- \. Patient currently participating in other studies unless approved by Sponsor in writing.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。