WATER IV PCa (AS Sub-study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aquablation Therapy, Active Surveillance.
- Who it may be relevant to
- Registry conditions: Localized Prostate Cancer. Basic parameters: from 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
Overview
The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.
Detailed description
The WATER IV AS sub-study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with low to intermediate risk localized prostate cancer who are candidates for active surveillance. Participants will be randomized to either Aquablation Therapy or active surveillance and followed up to 10 years.
Interventions
- Device Aquablation 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. - Other Active Surveillance
Active surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression. Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression.
Primary outcome measures
- Freedom from GG ≥ 2 [Time frame: 12 Months]
Secondary outcome measures (1)
- Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment [Time frame: 3 Years]
Eligibility criteria
Inclusion criteria
- Biological male with age ≥ 45 years at the time of consent
- Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
- First prostate cancer diagnoses within 18 months (545 days) of consent
- Are candidates for active surveillance
- Clinical Stage ≤ T2c
- PSA < 15 ng/ml
- Prostate volume ≥25 ml
Exclusion criteria
- 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:
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.
8\. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS/Likert ≥ 3).
9\. GG2 disease with PSA ≥ 10 OR stage ≥ T2b OR ≥ 50% of biopsy cores positive (multiple cores taken from any MRI visible lesion are counted as one continuous core).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 24 centers
- Arizona Clinical Trials — Chandler
- University of Southern California — Los Angeles
- Tri Valley Urology — Murrieta
- Boulder Medical Center — Boulder
- Advanced Research — Delray Beach
- University of Miami — Miami
- Georgia Urology — Atlanta
- Mountain View Hospital — Idaho Falls
- … and 16 more centers
Hong Kong · 1 center
- Chinese University of Hong Kong — Shatin
Identifiers
NCT: NCT07650448 · CSP0005 - AS Sub-study