Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-04 @ 7:05 PM
Study NCT ID:
NCT04284761
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053541', 'term': 'bicalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Biolen bicalutamide implant'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as measured by number and incidence of adverse events', 'timeFrame': 'change from baseline to radical prostatectomy up to 12 weeks after implantation', 'description': 'Adverse Events'}], 'secondaryOutcomes': [{'measure': 'change in prostate size', 'timeFrame': 'change from baseline to radical prostatectomy up to 12 weeks after implantation', 'description': 'prostate measurement by MRI'}, {'measure': 'change in tumor size', 'timeFrame': 'change from baseline to radical prostatectomy up to 12 weeks after implantation', 'description': 'tumor measurement by MRI'}, {'measure': 'change in Prostate Specific Antigen (PSA)', 'timeFrame': 'change from baseline to radical prostatectomy up to 12 weeks after implantation', 'description': 'PSA level'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma', 'Lower Urinary Tract Symptoms']}, 'descriptionModule': {'briefSummary': 'Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe.', 'detailedDescription': 'This prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. Study participants will have placement of the drug eluting Biolen and be followed through scheduled radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Study participant qualified and planning for radical prostatectomy.\n* At least 1 prostate lesion measurable by MRI \\> 0.5 cm within one month of screening.\n* PSA \\> 3 ng/mL within 3 months of screening.\n* Gleason score 3+4 or higher.\n* Study participant must be willing to undergo post-treatment imaging by MRI.\n* ECOG performance status 0 or 1.\n\nExclusion Criteria:\n\n* Prior radiotherapy or surgery for prostate cancer.\n* Prior or ongoing hormonal therapy for prostate cancer.\n* Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure.\n* Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.\n* Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.\n* Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of \\> 3 months.\n* Presence of any metastatic disease.\n* Prostate volume more than 80 cc at prior MRI imaging.\n* I-PSS score \\>20.\n* History of prostate infection.'}, 'identificationModule': {'nctId': 'NCT04284761', 'acronym': 'Biolen-PC', 'briefTitle': 'A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alessa Therapeutics Inc.'}, 'officialTitle': 'A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer', 'orgStudyIdInfo': {'id': 'CP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biolen', 'description': 'Biolen bicalutamide implant. Single implantation. In situ until prostatectomy', 'interventionNames': ['Combination Product: Bicalutamide implant']}], 'interventions': [{'name': 'Bicalutamide implant', 'type': 'COMBINATION_PRODUCT', 'description': 'Biolen bicalutamide implant', 'armGroupLabels': ['Biolen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Australian Clinical Trials', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'University of Wollongong', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '3112', 'city': 'Tauranga', 'state': 'North Island', 'country': 'New Zealand', 'facility': 'Tauranga Urology Research', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}], 'overallOfficials': [{'name': 'Pamela Munster, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alessa Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alessa Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}