Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02107404
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40', 'timeFrame': '40 Weeks'}], 'secondaryOutcomes': [{'measure': 'Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization', 'timeFrame': '104 Weeks'}, {'measure': 'Frequency of Adverse Events', 'timeFrame': '0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks'}, {'measure': 'Proportion of Patients with Objective disease progression within 2 years', 'timeFrame': '104 Weeks'}, {'measure': 'Number of Patients requiring further therapy at 2 years', 'timeFrame': '104 Weeks'}, {'measure': 'Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization', 'timeFrame': '104 Weeks'}, {'measure': 'Proportion of patients after RPE with biochemical relapse within 2 years of randomization', 'timeFrame': '104 Weeks'}, {'measure': 'Proportion of patients with progressive increase in PSA within 2 years of randomization', 'timeFrame': '104 Weeks'}, {'measure': 'Overall survival', 'timeFrame': '104 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Prostate Cancer', 'Biological', 'Vaccine'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male 18 years and older\n* Histologically confirmed pT2 prostate cancer\n* Post radical prostatectomy\n* PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months\n* Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n\nExclusion Criteria:\n\n* Confirmed brain and/or leptomeningeal metastases\n* Prior androgen deprivation therapy or orchiectomy for prostate cancer\n* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater\n* Other uncontrolled intercurrent illness\n* Treatment with immunotherapy against prostate cancer\n* Clinically significant cardiovascular disease\n* Active autoimmune disease requiring treatment'}, 'identificationModule': {'nctId': 'NCT02107404', 'briefTitle': 'Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sotio Biotech Inc.'}, 'officialTitle': 'Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial With Active Cellular Immunotherapy DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'SP003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCVAC/PCa Arm', 'description': 'Dendritic Cells DCVAC/PCA Experimental therapy', 'interventionNames': ['Biological: Dendritic Cells DCVAC/PCa']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Therapy', 'description': 'No Intervention'}], 'interventions': [{'name': 'Dendritic Cells DCVAC/PCa', 'type': 'BIOLOGICAL', 'description': 'DCVAC/PCa Experimental therapy', 'armGroupLabels': ['DCVAC/PCa Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Jablonec nad Nisou', 'country': 'Czechia', 'geoPoint': {'lat': 50.72431, 'lon': 15.17108}}, {'city': 'Jihlava', 'country': 'Czechia', 'geoPoint': {'lat': 49.3961, 'lon': 15.59124}}, {'city': 'Mníšek pod Brdy', 'country': 'Czechia', 'geoPoint': {'lat': 49.8665, 'lon': 14.26176}}, {'city': 'Nový Jičín', 'country': 'Czechia', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Pilsen', 'country': 'Czechia', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Uherské Hradiště', 'country': 'Czechia', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}], 'overallOfficials': [{'name': 'Tomas Scheiner, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sotio Accord'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOTIO a.s.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}