Health TrialsbyHealthPanel

WATER IV PCa (AS Sub-study)

ConditionLocalized Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorPROCEPT BioRobotics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Active Surveillance

    Other intervention

    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.

Treatment groups

333 Participants
are divided into 2 treatment groups
Group A: Aquablation TherapyExperimental treatment 1 intervention
Group B: Active SurveillanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from GG ≥ 2

Time frame
12 Months

Secondary outcomes

1

Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment

Time frame
3 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PROCEPT BioRobotics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: