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Active Not Recruiting
NCT06192758
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
Conditions: Prostate, Cancer
Sex: Male
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Boston Scientific Corporation
Location: Northwestern Memorial Hospital Chicago Illinois
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.
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. 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.
3. Subject with favorable intermediate risk clinically localized prostate cancer defined per NCCN Guidelines version 3.2022 as follows:
* Favorable intermediate-risk has all the following:
* i. One Intermediate Risk Factor (IRF):
1. cT2b-cT2c
2. Grade Group 2 or 3
3. PSA 10-20 ng/mL
* ii. Grade Group 1 or 2
* iii. \
Source: ClinicalTrials.gov (NCT06192758). StuddyBuddy aggregates publicly available trial information.
