Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06192758
Status:
SUSPENDED
Last Update Posted:
2025-12-22
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'C567350', 'term': 'Chromosome 2q32-Q33 Deletion Syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will be treated in cohorts at three sequential target absorbed radiation dose levels, where the dose level for the next cohort will be determined by a prespecified decision tree for escalation/de-escalation, according to the accelerated Time-to-Event Bayesian Optimal Interval Design (TITE-BOIN) approach.\n\n* Cohort size = 3 subjects\n* ≤15 subjects (or 5 cohorts) will be treated at any single dose level. ≤ 36 subjects (or 12 cohorts) will be treated in total across all doses. If no dose limiting toxicities are observed at any dose level, a minimum of 21 subjects will be treated'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'whyStopped': 'Due to predetermined protocol stopping criteria', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prostatic imaging assessment', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Qualitative analysis of multi-parametric MRI (mp-MRI) and PI-RADS score'}], 'primaryOutcomes': [{'measure': 'Maximum tolerated radiation dose of TheraSphere PCa', 'timeFrame': 'Through 90 days post-treatment', 'description': '• The Maximum Tolerated Dose (MTD) of Yttrium-90 Glass Microspheres (TheraSphere™ PCa) is based on rate of dose limiting toxicity (DLT) through 90 days, defined as any ≥ grade 3 adverse event (AE) according to CTCAE v.5'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Through 5 years post-treatment (acute ≤ 90 days and late > 90 days)', 'description': 'The following AEs/SAEs will be assessed in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0:\n\n* Rate of any ≥ grade 3 AEs\n* Rate of AEs of interest, i.e., any ≥ Grade 2 GI/GU and erectile dysfunction toxicities\n* Rate of any treatment-emergent AEs and treatment-emergent SAEs\n* Rate of any treatment-related AEs and treatment-related SAEs\n* AEs related to non-target TheraSphere PCa distribution'}, {'measure': 'Rate of success of delivering intended dose', 'timeFrame': 'Immediately post-treatment', 'description': '• The ability to deliver the intended TheraSphere PCa absorbed dose (+/- 20%) to the treatment volume based on post-treatment PET derived absorbed dose.'}, {'measure': 'Recurrence Free Survival', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Biochemical Recurrence Free Survival (bRFS) based on PSA according to the Phoenix criteria (RTOG-ASTRO definition). Biochemical recurrence of prostate cancer after curative treatment is defined as a PSA rise of ≥ 2 ng/mL above the post-treatment nadir.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Progression free survival (PFS) and local progression free survival (LPFS), defined as time from inclusion until one of the following events, whichever comes first: biochemical progression (Phoenix criteria) or clinical progression.'}, {'measure': 'Prostate cancer specific survival', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Prostate cancer specific survival will be measured as the number of days between treatment with TheraSphere PCa and death by prostate cancer.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through 5 years post-treatment', 'description': '• OS will be measured as the number of days between treatment with TheraSphere PCa and death by any cause.'}, {'measure': 'Rate of subsequent prostate anticancer treatment', 'timeFrame': 'Through 5 years post-treatment', 'description': '• A summary table with number of subjects (%) who received subsequent definitive or systematic therapy and type of therapies received will be presented.'}, {'measure': 'Rate of histopathological recurrence', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Rate of recurrence based on histopathological assessment of prostate MR/US-fusion biopsy in patients with evidence of progression.'}, {'measure': 'Quality of Life (QoL) measured by EPIC-26', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Change from baseline measured through Expanded Prostate Cancer Index Composite (EPIC-26).'}, {'measure': 'Quality of Life (QoL) measured by MSHQ', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Change from baseline measured through Male Sexual Health Questionnaire (MSHQ).'}, {'measure': 'Quality of Life (QoL) measured by I-PSS', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Change from baseline measured through International Prostate Symptom Score (I-PSS).'}, {'measure': 'Maximum urinary flow (Qmax)', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Change from baseline'}, {'measure': 'Post-void residual (PVR) urine test', 'timeFrame': 'Through 5 years post-treatment', 'description': '• Change from baseline'}, {'measure': 'Dose Distribution', 'timeFrame': 'Through one-week post-treatment', 'description': '• Dose Volume Histogram (DVH) and evaluation of D90 from post-treatment Y90 PET-MRI/CT.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiation', 'TheraSphere', 'Y90', 'Yttrium-90', 'Glass', 'Microspheres'], 'conditions': ['Prostate', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '33839262', 'type': 'BACKGROUND', 'citation': 'Mouli SK, Raiter S, Harris K, Mylarapu A, Burks M, Li W, Gordon AC, Khan A, Matsumoto M, Bailey KL, Pasciak AS, Manupipatpong S, Weiss CR, Casalino D, Miller FH, Gates VL, Hohlastos E, Lewandowski RJ, Kim DH, Dreher MR, Salem R. Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation. J Vasc Interv Radiol. 2021 Aug;32(8):1103-1112.e12. doi: 10.1016/j.jvir.2021.01.282. Epub 2021 Apr 9.'}, {'pmid': '29769209', 'type': 'BACKGROUND', 'citation': 'Yuan Y, Lin R, Li D, Nie L, Warren KE. Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clin Cancer Res. 2018 Oct 15;24(20):4921-4930. doi: 10.1158/1078-0432.CCR-18-0246. Epub 2018 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere PCa device in patients with clinically localized prostate cancer across US-based centers.', 'detailedDescription': "TheraSphere™ Y-90 Glass Microspheres are a targeted cancer therapy consisting of tiny glass beads containing radioactive Yttrium-90 (Y-90), which are injected directly into the blood vessel feeding the tumor through a microcatheter using advanced imaging guidance. The glass microspheres enter the tumor's blood supply, lodge within the blood vessels feeding the tumor, and release radiation to the tumor. The radiation works to destroy the tumor cells from within, thus limiting radiation exposure to surrounding normal tissues, a process referred to as selective internal radiation therapy (SIRT).\n\nThis study aims to investigate the maximum safe radiation dose of TheraSphere Prostate Cancer (PCa) device that can be delivered in patients with clinically localized prostate cancer. The study will also evaluate the full safety profile, technical feasibility, efficacy, and quality of life metrics of the TheraSphere PCa device.\n\nParticipants will be asked to complete the following:\n\n* At least two image-guided visits, including a mapping assessment (without Technetium Tc albumin aggregated \\[Tc-MAA\\]) prior to treatment\n* One treatment visit, including image-guided assessments\n* Fifteen post-treatment follow-up visits for a total of approximately 20 visits over the 5-year study period\n\nNote: the VOYAGER Study is a staged investigational device exemption (IDE) study; therefore, the full enrollment of 21 to 36 subjects is subject to FDA approval following safety review of the first 10 subjects enrolled."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject has ability to comprehend and willingness to sign and date the IRB-approved study informed consent form (ICF), and to comply with the study testing, procedures, and follow-up schedule.\n2. Histologic confirmation of adenocarcinoma of the prostate by MR-fusion biopsy. Referral biopsy for eligibility must be completed between 180 days and 6 weeks prior to mapping procedure.\n3. Subject with favorable intermediate risk clinically localized prostate cancer defined per NCCN Guidelines version 3.2022 as follows:\n\n * Favorable intermediate-risk has all the following:\n * i. One Intermediate Risk Factor (IRF):\n\n 1. cT2b-cT2c\n 2. Grade Group 2 or 3\n 3. PSA 10-20 ng/mL\n * ii. Grade Group 1 or 2\n * iii. \\<50% biopsy cores positive (e.g., \\<6 of 12 cores)\n4. Staging MRI must confirm American Joint Committee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c.\n5. Whole prostate gland volume ≥ 60 cc (measured on MRI)\n6. International Prostate Score Symptom (I-PSS) ≤ 18\n7. Estimated life expectancy of \\>5 years according to NCCN guideline's tools (NCCN v03.2022) who has declined or is ineligible for Standard of Care treatments (observation, active surveillance, surgery, and radiation therapies \\[brachytherapy/external beam radiation therapy\\])\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n9. Angiographic inclusion criteria:\n\n * a. Type I to IV prostate artery origins on both hemiglands.1\n * b. No evidence of procedure limiting vascular abnormalities (aneurysms, stenosis, shunt, fistula, occlusion) or morphologic asymmetric single prostate artery on either side (hemigland)\n * c. Bilaterally accessible solitary prostatic arteries.\n * d. Complete perfusion of the prostate gland via a single dominant vessel for each hemigland\n10. Have adequate organ and bone marrow function within 30 days prior to index procedure, as defined below:\n\n * a. International Normalized Ratio (INR) ≤ 1.2 (in absence of anticoagulation)\n * b. Platelets ≥ 75,000/L\n * c. GFR ≥ 40 mL/min/1.73m2\n * d. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L\n * e. Hemoglobin (Hgb) ≥ 9.0 g/dL (Note: the use of transfusion or other intervention to achieve adequate bone marrow function is acceptable\n * f. ALT/AST ≤ 5 x upper limit of normal (ULN)\n * g. Bilirubin ≤ 2 mg/dL\n11. Patients with known Human Immunodeficiency Virus (HIV) infection are eligible with well controlled HIV infection, no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells/uL\n\nExclusion Criteria:\n\n1. Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)\n2. Histological evidence of intraductal features\n3. Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization \\[PAE\\], transurethral resection of the prostate \\[TURP\\] or previous/ planned hormonal therapy\n4. History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter\n5. Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder\n6. Prior significant rectal surgery (haemorrhoidectomy is acceptable)\n7. Prior invasive malignancy unless disease free for a minimum of 3 years. Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease\n8. Hip prosthesis\n9. Medical contraindication to undergo contrast-enhanced angiography, CT scan and magnetic resonance imaging (MRI), or arterial catheterization, or known history of hypersensitivity reactions to iodinated and gadolinium-based contrast product\n10. Angiographic exclusion criteria:\n\n * a. Perfusion to tissues outside the Planning Target Volume (PTV) that cannot be corrected by placement of the catheter distal to collateral vessels or the application of standard angiographic techniques, such as coil embolization\n * b. Type V prostatic artery origin on either side"}, 'identificationModule': {'nctId': 'NCT06192758', 'acronym': 'VOYAGER', 'briefTitle': 'Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'S2493'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TheraSphere PCa Dose Escalation', 'description': 'Participants will be treated in cohorts of three across three sequential dose levels:\n\n* Dose Level 1 (or starting dose) = 175 Gy; however, a provisional lower dose level, Dose Level -1 = 150 Gy, may be utilized in case de-escalation is warranted at Dose Level 1.\n* Dose Level 2 = 200 Gy\n* Dose Level 3 = 225 Gy', 'interventionNames': ['Device: TheraSphere PCa']}], 'interventions': [{'name': 'TheraSphere PCa', 'type': 'DEVICE', 'otherNames': ['TheraSphere PCa - Yttrium-90 Glass Microspheres'], 'description': 'Single session treatment of TheraSphere PCa - Yttrium-90 Glass Microspheres for the treatment of prostate cancer. Dose vials will be available in activity ranging from 0.1 GBq (2.7 mCi) to 3 GBq (81 mCi).', 'armGroupLabels': ['TheraSphere PCa Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center (UCLA Health, Los Angeles)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami (Sylvester Comprehensive Cancer Center)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Samdeep Mouli, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern Medical Hospital'}, {'name': 'Mark Hurwitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westchester Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}