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Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device

Study acronym: VOYAGER
StatusActive, Not Recruiting
PhaseNot applicable
Started2024-04-15
View on ClinicalTrials.gov ↗

Amendment history

2026-08-25
6 amendments v28-v33
6 re-verifications since 2026-03-24, no change to tracked fields
2026-02-26
Suspended→Active, Not Recruiting Study Status, Contacts/Locations v27
Trial statusSuspended→Active, Not Recruiting
Reason stoppedDue to predetermined protocol stopping criteria→not stated
Study sites5→1
2026-01-28
4 amendments v23-v26
4 re-verifications since 2025-10-31, no change to tracked fields
2025-09-10
Recruiting→Suspended Study Status, Contacts/Locations v22
Trial statusRecruiting→Suspended
Reason stoppednot stated→Due to predetermined protocol stopping criteria
Study sitesdetails revised at 5 of 5 sites
2025-08-21
Study Status, Oversight, Contacts/Locations v21
Study sitescontacts updated at 1 of 5 sites
Show 20 earlier versions
2025-08-04
Study Status, Oversight, Contacts/Locations v20
Study sitescontacts updated at 2 of 5 sites
2025-06-26
3 amendments v17-v19
3 re-verifications since 2025-04-24, no change to tracked fields
2025-03-27
Study Status, Contacts/Locations v16
Study sitescontacts updated at 3 of 5 sites
2025-02-18
Study Identification, Study Status v15
Study title-15 characters
First In Human Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
2025-01-31
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v14
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 5 of 5 sites
2025-01-27
Study Status v13
Primary completion date2027-11→2028-01
Completion date2032-08→2032-10
2024-12-23
Study Status v12
Re-verified, no change to tracked fields
2024-11-26
Suspended→Active, Not Recruiting Study Status, Eligibility v11
Trial statusSuspended→Active, Not Recruiting
Reason stoppedDue to predetermined protocol criteria (not related to patient safety)→not stated
Eligibility criteria+84 characters
[...] ee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c. Whole prostate gland volume ≥ 60 cc (measured on MRI) International Prostate Score Symptom (I-PSS) ≤ 18 Estimated [...] st product Angiographic exclusion criteria: a. Perfusion to extra-prostatictissues tissuesoutside the Planning Target Volume (PTV) that cannot be corrected by placement of the catheter distal to [...]
2024-10-25
5 amendments v6-v10
5 re-verifications since 2024-06-27, no change to tracked fields
2024-05-15
Recruiting→Suspended Study Status, Contacts/Locations v5
Trial statusRecruiting→Suspended
Reason stoppednot stated→Due to predetermined protocol criteria (not related to patient safety)
Study sitesdetails revised at 5 of 5 sites
2024-04-29
Study Status v4
Start dateestimated 2024-04→confirmed 2024-04-15
2024-03-26
Study Status v3
Start date2024-02-27→2024-04
2024-02-29
Study Status, Contacts/Locations v2
Start date2024-01-08→2024-02-27
Study sitescontacts updated at 1 of 5 sites
2024-01-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01→confirmed 2024-01-08
Study sitesdetails revised at 5 of 5 sites
2023-12-21
Original filing
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.
Trial Details
NCT Number NCT06192758
Lead Sponsor Boston Scientific Corporation
Conditions Prostate, Cancer
Enrollment 36 participants
Start Date 2024-04-15
Primary Completion 2028-01 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-28