Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
NCT06192758 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-04-29
Summary
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.
Conditions
Interventions
- DEVICE
-
TheraSphere PCa
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).
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Samdeep Mouli, M.D., M.S. · Northwestern Medical Hospital
-
Mark Hurwitz, MD · Westchester Medical Center
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-15
- Primary Completion
- 2028-01-31
- Completion
- 2032-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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