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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquablation Therapy | Experimental | The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System |
|
| Radical Prostatectomy | Active Comparator | The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquablation Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of pad use for urinary incontinence | 6 Months | |
| Rate of erectile dysfunction | 6 Months |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State Urological Institute | Chandler | Arizona | 85224 | United States | ||
| East Valley Urology Center |
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|
| Radical Prostatectomy | Procedure | 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. |
|
| 1 Year |
| Mesa |
| Arizona |
| 85206 |
| United States |
| University of Southern California | Los Angeles | California | 90089 | United States |
| Boulder Medical Center | Boulder | Colorado | 80304 | United States |
| Advanced Research | Delray Beach | Florida | 33484 | United States |
| University of Miami | Miami | Florida | 33146 | United States |
| Florida Urology Partners | Tampa | Florida | 33606 | United States |
| Trophy Point Urology | Tampa | Florida | 33607 | United States |
| Georgia Urology | Atlanta | Georgia | 30328 | United States |
| Mountain View Hospital | Idaho Falls | Idaho | 83401 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Endeavor Health | Glenview | Illinois | 60026 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Kansas City Urology Care | North Kansas City | Missouri | 64116 | United States |
| Kearney Urology Center | Kearney | Nebraska | 68847 | United States |
| Adult & Pediatric Urology | Omaha | Nebraska | 68114 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Integrated Medical Professionals, PLLC | New York | New York | 10016 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Tidelands Health Urology | Murrells Inlet | South Carolina | 29576 | United States |
| Urology Austin | Austin | Texas | 78745 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| Potomac Urology | Alexandria | Virginia | 22311 | United States |
| Advocate Aurora Research Institute | Sheboygan | Wisconsin | 53081 | United States |
| University of Toronto | Toronto | Ontario | M5S3H2 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 0A9 | Canada |
| Universitätsklinikum OWL der Universität Bielefeld | Bielefeld | Germany |
| Chinese University of Hong Kong | Shatin | Hong Kong |
| Hospital da Cruz Vermelha | Lisbon | 1549-008 | Portugal |
| National Taiwan University Hospital | Taipei | Taiwan |
| Hampshire Hospitals NHS Foundation Trust | Basingstoke | Hamsphire | RG24 7A | United Kingdom |
| Norfolk & Norwich University Hospital | Colney | Norwich | NR4 7UY | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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