这是一项多中心、前瞻性、随机临床试验，旨在评估 Aquablation 治疗用于低风险至中风险至高风险局部前列腺癌男性的安全性及疗效，该等男性为前列腺切除术的适合人选或已选择接受前列腺切除术。参加者将被随机分配接受 Aquablation 治疗或根治性前列腺切除术，并随访长达 10 年。
适应症：Localized Prostate Cancer
入组条件
纳入标准
- 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
排除标准
- 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。