Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-28 @ 11:48 PM
Study NCT ID:
NCT06134232
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C511774', 'term': 'sipuleucel-T'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'AN OPEN-LABEL, MULTICENTER STUDY OF SUBJECTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER TREATED WITH PROVENGE AND BOOSTED WITH A SINGLE INFUSION OF SIPULEUCEL-T TO MEASURE IMMUNE RESPONSE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess biomarkers of response to treatment', 'timeFrame': 'Once all subjects have completed the study through the 5 year Overall Survival Period', 'description': 'Biomarkers, such as cytokines, will be assessed for response to booster treatment using appropriate descriptive statistics assessed over time and at Week 28. Nominal p-values will be provided without multiplicity adjustment .appropriate descriptive statistics assessed over time and at Week 28.'}, {'measure': 'Assess Antigen Response', 'timeFrame': 'Once all subjects have completed the study through the 5 year Overall Survival Period', 'description': 'Comparison of (over time and at Week 38), the number of subjects per treatment arm with PAP and PA2024 antigen positive response using descriptive statistics.'}], 'primaryOutcomes': [{'measure': 'Assess humoral immune response to PAP and PA2024 after booster infusion', 'timeFrame': 'Once all subjects have completed the study through the 5 year Overall Survival Period', 'description': 'To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not'}], 'secondaryOutcomes': [{'measure': 'Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T', 'timeFrame': 'Once all subjects have completed the study through the 5 year Overall Survival Period', 'description': 'For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups.'}, {'measure': 'Evaluate Overall Survival', 'timeFrame': 'Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating', 'description': 'Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single Dose', 'Sipuleucel-T', 'Immune Response Rate', 'Safety', 'Adenocarcinoma of the Prostate'], 'conditions': ['Metastatic Castration-Resistant Prostate Cancer (mCRPC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.dendreon.com/science-and-services/provenge-prostate-cancer-immunotherapy/', 'label': 'Dendreon Clinical Trial Summary Webpage'}]}, 'descriptionModule': {'briefSummary': 'A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).', 'detailedDescription': 'Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male at birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor a subject to be eligible for participation in this study, all of the following criteria must be satisfied:\n\n1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \\[hormone refractory\\] prostate cancer).\n2. Have qualified for on-label PROVENGE® infusion\n3. Have received all 3 infusions of PROVENGE® prior to randomization\n4. Written informed consent provided prior to the initiation of study procedures\n5. Estimated life expectancy ≥12 months\n\nExclusion Criteria:\n\nA subject will not be eligible for participation in this study if any of the following criteria apply.\n\n1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \\[hormone refractory\\] prostate cancer).\n2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)\n3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.\n4. On experimental or investigational therapy.'}, 'identificationModule': {'nctId': 'NCT06134232', 'acronym': 'ProvONE', 'briefTitle': 'Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dendreon'}, 'officialTitle': 'An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response', 'orgStudyIdInfo': {'id': 'P23-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Booster Arm', 'description': 'Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion.\n\nSubjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events.', 'interventionNames': ['Drug: Sipuleucel-T Injection']}, {'type': 'NO_INTERVENTION', 'label': 'No Booster', 'description': 'No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events.'}], 'interventions': [{'name': 'Sipuleucel-T Injection', 'type': 'DRUG', 'description': 'Single Infusion', 'armGroupLabels': ['Booster Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85741', 'city': 'Tuscon', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kalpesh Patel, MD', 'role': 'CONTACT', 'email': 'kpatel@arizonauro.com', 'phone': '520 618 1010'}], 'facility': 'Arizona Urology Specialists'}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tanya Dorff Principal Investigator, MD', 'role': 'CONTACT', 'email': 'mtuano@coh.org', 'phone': '626-218-6585'}], 'facility': 'City of Hope - National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Schiff, MD', 'role': 'CONTACT', 'email': 'drschiff@urologyassociates.net', 'phone': '559 321 2800'}], 'facility': 'Urology Associates of Central California Medical Group', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Dato, MD', 'role': 'CONTACT', 'email': 'Paul.Dato@UnioHP.com', 'phone': '858 279 7050', 'phoneExt': '2676'}], 'facility': 'Unio Health Partners - Genesis Research, LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Cahn, MD', 'role': 'CONTACT', 'email': 'dcahn@coloradouro.com', 'phone': '303-996-9649'}], 'facility': 'Colorado Urology', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Evan Fynes, MD', 'role': 'CONTACT', 'email': 'Evan.fynes@auihealth.com', 'phone': '386 239 8500'}], 'facility': 'Advanced Urology Institute', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33771', 'city': 'Largo', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Truesdale, MD', 'role': 'CONTACT', 'email': 'matthew.truesdale@auihealth.com', 'phone': '813 245 3782'}], 'facility': 'Advanced Urology Institute', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward King, MD', 'role': 'CONTACT', 'email': 'edward.king@auihealth.com', 'phone': '352 430 0705'}], 'facility': 'Advanced Urology Institute', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33578', 'city': 'Riverview', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Engelman, MD', 'role': 'CONTACT', 'email': 'aengelman@floridaurologypartners.com', 'phone': '813-981-3931'}], 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.86614, 'lon': -82.32648}}, {'zip': '60415', 'city': 'Chicago Ridge', 'state': 'Illinois', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Associated Urological Specialists', 'geoPoint': {'lat': 41.70142, 'lon': -87.77922}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Pearl, MD', 'role': 'CONTACT', 'email': 'jpearl@uropartners.com', 'phone': '847-823-3185'}], 'facility': 'UroPartners', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '60451', 'city': 'New Lenox', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Greg Andros, MD', 'role': 'CONTACT', 'email': 'DrAndros@advuro.com', 'phone': '815 409 4930'}], 'facility': 'Advanced Urology Associates', 'geoPoint': {'lat': 41.51198, 'lon': -87.96561}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth Ney, MD', 'role': 'CONTACT', 'email': 'kney@urologyin.com', 'phone': '317 564 5159'}], 'facility': 'Urology of Indiana', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ryan Malone, MD', 'role': 'CONTACT', 'email': 'rmalone@1sturology.com', 'phone': '812-670-2755'}], 'facility': 'First Urology', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '46410', 'city': 'Merrillville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Manoj Rao, MD', 'role': 'CONTACT', 'email': 'mrao@urologic-specialists.com', 'phone': '219 259 1291'}], 'facility': 'Urologic Specialists of Northwest Indiana', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ronald Tutrone, MD', 'role': 'CONTACT', 'email': 'rtutrone@uniteduro.com', 'phone': '443 471 5741'}], 'facility': 'Chesapeake Urology Research Associates', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Hafron, MD', 'role': 'CONTACT', 'email': 'hafronj@michiganurology.com', 'phone': '248 786 0467'}], 'facility': 'Michigan Institute of Urology', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brittany Minor', 'role': 'CONTACT', 'email': 'brittany.minor@objective.health', 'phone': '314-806-3921'}], 'facility': 'Specialty Clinical Research of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11040', 'city': 'North Hills', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jed Kaminetsky, MD', 'role': 'CONTACT', 'email': 'jkaminetsky@imppllc.com', 'phone': '212 480 3333'}], 'facility': 'Integrated Medical Professionals', 'geoPoint': {'lat': 40.78093, 'lon': -73.67652}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Pieczonka, MD', 'role': 'CONTACT', 'email': 'cpieczonka@ampofny.com', 'phone': '315 558 6619'}], 'facility': 'Associated Medical Professionals of NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Jalkut, MD', 'role': 'CONTACT', 'email': 'mjalkut@gmail.com', 'phone': '919 390 7368'}], 'facility': 'Associated Urologists of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Pliskin, MD', 'role': 'CONTACT', 'email': 'mpliskin@urologygroup.com', 'phone': '513 841 7550'}], 'facility': 'The Urology Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43230', 'city': 'Gahanna', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Martin, MD', 'role': 'CONTACT', 'email': 'bmartin@centralohiourology.com', 'phone': '614 396 2684'}], 'facility': 'Central Ohio Urology Group', 'geoPoint': {'lat': 40.01923, 'lon': -82.87934}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bryan Mehlhaff, MD', 'role': 'CONTACT', 'email': 'bryan@oregonurology.com', 'phone': '541 284 5508'}], 'facility': 'Oregon Urology Institute', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurence Belkoff, MD', 'role': 'CONTACT', 'email': 'lbelkoff@midlanticurology.com', 'phone': '610 667 0458'}], 'facility': 'MidLantic Urology', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Sieber, MD', 'role': 'CONTACT', 'email': 'krisb@midlanticurology.com', 'phone': '717 431 2285'}], 'facility': 'Keystone Urology Specialists', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Ellett, MD', 'role': 'CONTACT', 'email': 'jellett@lcurology.com', 'phone': '843 572 1010'}], 'facility': 'Lowcountry Urology Institute', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neal Shore, MD', 'role': 'CONTACT', 'email': 'kate.valipour@startresearch.com', 'phone': '843-449-1010', 'phoneExt': '5268'}], 'facility': 'Carolina Urologic Research Center, LLC', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Morris, MD', 'role': 'CONTACT', 'email': 'ctrotter@ua-pc.com', 'phone': '615-250-9268'}], 'facility': 'Urology Associates of Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Given, MD', 'role': 'CONTACT', 'email': 'abohannon@urologyofva.net', 'phone': '757 452 3486'}], 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raymond Lance, MD', 'role': 'CONTACT', 'email': 'Amyb@spokaneurology.com', 'phone': '509 747 3147', 'phoneExt': '112'}], 'facility': 'Spokane Urology', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'centralContacts': [{'name': 'Margaret Warner-Lubin', 'role': 'CONTACT', 'email': 'ProvONE@dendreon.com', 'phone': '2064588358'}], 'overallOfficials': [{'name': 'Nadeem Sheikh, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dendreon Pharmaceuticals, LLC'}, {'name': 'Benjamin Lowentritt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chesapeake Urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Based on precedent, only IPD used in the results publication may be shared; however, the internal Dendreon team has not yet discussed this.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dendreon', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'WCG IRB', 'class': 'UNKNOWN'}, {'name': 'Talosix', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}