Water IV: See if Aquablation helps localized prostate cancer patients choose active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The WATER IV AS sub-study is a multicenter, prospective, randomized comparison between Aquablation therapy and active surveillance in men with low to intermediate risk localized prostate cancer. Eligible participants are men 45 or older with biopsy-confirmed Grade Group 1 or 2 cancer and willing to be managed with active surveillance if assigned to that arm. Participants are followed for up to 10 years to assess safety and efficacy outcomes. The study is led by PROCEPT BioRobotics with sites in Arizona and California. Primary endpoints focus on safety, cancer control, and patient-reported outcomes to determine if Aquablation can offer a viable alternative to immediate intervention in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Biological male with age ≥ 45 years at the time of consent
2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
3. First prostate cancer diagnoses within 18 months (545 days) of consent
4. Are candidates for active surveillance
5. Clinical Stage ≤ T2c
6. PSA \< 15 ng/ml
7. 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.

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).

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Advanced Research
  Delray Beach, Florida, United States Recruiting
• Georgia Urology
  Atlanta, Georgia, United States Recruiting
• Mountain View Hospital
  Idaho Falls, Idaho, United States Recruiting
• Endeavor Health
  Glenview, Illinois, United States Recruiting
• Kearney Urology Center
  Kearney, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Angela Lee
• Email: a.lee@procept-biorobotics.com
• Phone: 650-232-7215

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Whole-gland prostate dose boost versus SBRT alone for PSMA-staged localized and locally advanced prostate cancer

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• Oxybutynin ER to help early urinary continence after robotic prostatectomy

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• Comparing adaptive SBRT to standard image-guided SBRT for localized prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.