Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:43 PM
Study NCT ID:
NCT06054867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.', 'timeFrame': '12 months post-treatment', 'description': 'The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['AQUABEAM', 'Aquablation', 'Aquablation therapy', 'Robotic Waterjet Treatment', 'RWT', 'Prostate cancer'], 'conditions': ['Localized Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Stage ≤ T2c\n* PSA ≤ 20 ng/ml\n* Prostate volume ≥ 30 ml\n* Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core.\n\nExclusion Criteria:\n\n* Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy.\n* Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months.\n* Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.\n* Evidence of bone metastasis.\n* Evidence of extracapsular involvement.\n* Evidence of seminal vesicle invasion on DRE or MRI read as "definite", "probable" or "consistent with"\n* Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.'}, 'identificationModule': {'nctId': 'NCT06054867', 'briefTitle': 'PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System', 'organization': {'class': 'INDUSTRY', 'fullName': 'PROCEPT BioRobotics'}, 'officialTitle': 'PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System', 'orgStudyIdInfo': {'id': 'CSP0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquablation', 'interventionNames': ['Device: Robotic Waterjet Treatment']}], 'interventions': [{'name': 'Robotic Waterjet Treatment', 'type': 'DEVICE', 'otherNames': ['Aquablation therapy'], 'description': "The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System.\n\nDuring 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.", 'armGroupLabels': ['Aquablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Institute of Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Grossman School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PROCEPT BioRobotics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}