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WATER IV PCa (AS Sub-study)

18. juni 2026 opdateret af: PROCEPT BioRobotics

WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

333

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Arizona State Urological Institute
    • California
      • Los Angeles, California, Forenede Stater, 90089
        • University of Southern California
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Boulder Medical Center
    • Florida
      • Miami, Florida, Forenede Stater, 33146
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30328
        • Georgia Urology
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83401
        • Mountain View Hospital
    • Illinois
      • Glenview, Illinois, Forenede Stater, 60026
        • Endeavor Health
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University
    • Missouri
      • North Kansas City, Missouri, Forenede Stater, 64116
        • Kansas City Urology Care
    • Nebraska
      • Kearney, Nebraska, Forenede Stater, 68847
        • Kearney Urology Center
      • Omaha, Nebraska, Forenede Stater, 68114
        • Adult & Pediatric Urology
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • MUSC Hollings Cancer Center
      • Murrells Inlet, South Carolina, Forenede Stater, 29576
        • Tidelands Health Urology
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Urology Clinics of North Texas
    • Wisconsin
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Advocate Aurora Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Akvablationsterapi
Akvablationsterapiarmen vil modtage akvablation med enten AQUABEAM Robotic System eller HYDROS Robotic System
Enhed: Akvablationsterapi
AquaBeam Robotic System og HYDROS Robotic System anvender højhastigheds steril saltvandsvandstråle til at resektere prostatavæv, styret af realtidsvisualisering gennem cystoskopi og transrektal ultralydsbilleddannelse. Denne minimalt invasive kirurgiske procedure kaldes akvablationsterapi.
Aktiv komparator: Active Surveillance
The active surveillance arm will receive standard-of-care for prostate cancer management.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Freedom from GG ≥ 2
Tidsramme: 12 Months
12 Months

Sekundære resultatmål

Resultatmål
Tidsramme
Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment
Tidsramme: 3 Years
3 Years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PROCEPT BioRobotics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2038

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSP0005 - AS Sub-study

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akvablationsterapi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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