Benign Prostatic HyperplasiaNCT06051942
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
A study testing Robotic Waterjet Treatment in people with Benign Prostatic Hyperplasia and Localized Prostate Cancer, run by PROCEPT BioRobotics at 6 sites in 4 countries.
Trial summary
The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Localized Prostate Cancer
- What is being tested?
- Robotic Waterjet Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 22 Nov 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- International Prostate Symptom Score (IPSS) ≥ 8
- Gleason Grade Group 1-3
- Prostate-specific Antigen (PSA) ≤20ng/mL
- Cancer stage less than or equal to T2c
Who cannot join
- Patients with previous surgical treatment of benign prostatic hyperplasia
- MRI evidence of extracapsular extension of cancer
- Any severe illness that would prevent complete study participation or confound study results
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Potomac Urology Center
Alexandria, Virginia, 22311
Endeavour Health (NorthShore University HealthSystem)
Glenview, Illinois, 60026
San Diego Clinical Trials
La Mesa, California, 91942
About this study
The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
- Being tested
- Robotic Waterjet Treatment
- Keywords
- AQUABEAM, AQUABEAM Robotic System, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer, Lower urinary tract symptoms, LUTS, BPH
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Waterjet TreatmentDevice
Also called Aquablation therapy
The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Aquablation | Experimental | Not described Receives: Device: Robotic Waterjet Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment.
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start22 Nov 2022
- Primary completionJul 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- PROCEPT BioRobotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051942
- Sponsor's protocol ID
- CSP0003
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
- ClinicalTrials.gov ID
- NCT06051942
- Acronym / sponsor ID
- CSP0003
- Keywords
- AQUABEAM, AQUABEAM Robotic System, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer, Lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquablation | Experimental | Device: Robotic Waterjet Treatment |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- International Prostate Symptom Score (IPSS) ≥ 8
- Gleason Grade Group 1-3
- Prostate-specific Antigen (PSA) ≤20ng/mL
- Cancer stage less than or equal to T2c
Key exclusion criteria (3 listed)
- Patients with previous surgical treatment of benign prostatic hyperplasia
- MRI evidence of extracapsular extension of cancer
- Any severe illness that would prevent complete study participation or confound study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Waterjet TreatmentAlso: Aquablation therapyThe Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan. | Device | Aquablation |
Primary outcome
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Time frame: 3 months post-treatment
Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Waterjet Treatment in people with Benign Prostatic Hyperplasia and Localized Prostate Cancer, run by PROCEPT BioRobotics at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Hong Kong, Lebanon, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment (time frame: 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.