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Clinical Trial · NCT06192758
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.
Overview
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.
Sponsor
Boston Scientific Corporation
Phase
N/A
Contacts
McAnthony Tarway
mcanthony.tarway@bsci.com
615-580-1320
Shirley Nyepah
shirley.nyepah@bsci.com
612-300-7205
ClinicalTrials.gov
NCT06192758Drug / Compound
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
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