Localized Prostate Cancer
Conditions
Keywords
Aquablation therapy, Aquablation, Prostate cancer, AQUABEAM, radical prostatectomy, HYDROS
Brief summary
This is a multicenter, prospective, randomized clinical trial that aims to assess the safety and efficacy of Aquablation Therapy in men with low-risk to intermediate to high-risk localized prostate cancer who are candidates for, or have opted for, prostatectomy. Participants will be randomized to either Aquablation Therapy or radical prostatectomy and followed up to 10 years.
Interventions
DEVICEAquablation Therapy
The AquaBeam Robotic System and the HYDROS Robotic System utilize high-velocity sterile saline waterjet to resect prostate tissue, guided by real-time visualization through cystoscopy and transrectal ultrasound imaging. This minimally invasive surgical procedure is called the Aquablation therapy.
PROCEDURERadical Prostatectomy
Radical prostatectomy is a surgery that is performed through an incision in the lower abdomen or perineum, or with a laparoscope or robotic system to remove the entire prostate gland.
Sponsors
PROCEPT BioRobotics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Biological male with age ≥ 45 years at the time of consent 2. Biopsy positive Grade Group 1-3 prostate cancer 3. Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment. 4. Clinical Stage ≤ T2c 5. PSA ≤ 20 ng/ml 6. Prostate volume ≥25 ml
Exclusion criteria
1. 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. 2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment. 3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion. 4. Patient is unwilling to accept a blood transfusion if required. 5. 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: 5a. 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). 6\. 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. 7\. Patient currently participating in other studies unless approved by Sponsor in writing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pad use for urinary incontinence | 6 Months |
| Rate of erectile dysfunction | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of pad use for urinary incontinence | 3 Months |
| Rate of erectile dysfunction | 3 Months |
| Stable or improved Grade Group at 1 year compared to baseline (Aquablation arm only) | 1 Year |
Countries
Canada, Germany, Hong Kong, Portugal, Taiwan, United Kingdom, United States
Outcome results
None listed