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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06051942




Registration number
NCT06051942
Ethics application status
Date submitted
18/09/2023
Date registered
25/09/2023
Date last updated
7/08/2025

Titles & IDs
Public title
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
Scientific title
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
Secondary ID [1] 0 0
CSP0003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Localized Prostate Cancer 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Robotic Waterjet Treatment

Experimental: Aquablation -


Treatment: Devices: Robotic Waterjet Treatment
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Timepoint [1] 0 0
3 months post-treatment

Eligibility
Key inclusion criteria
* 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
Minimum age
No limit
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Lebanon
State/province [6] 0 0
Beirut
Country [7] 0 0
New Zealand
State/province [7] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PROCEPT BioRobotics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Angela Lee
Address 0 0
Country 0 0
Phone 0 0
650-232-7215
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06051942