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.
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). This 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. Participants will be asked to complete the following: * At least two image-guided visits, including a mapping assessment (without Technetium Tc albumin aggregated \[Tc-MAA\]) prior to treatment * One treatment visit, including image-guided assessments * Fifteen post-treatment follow-up visits for a total of approximately 20 visits over the 5-year study period Note: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
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).
Northwestern Memorial Hospital
Chicago, Illinois, United States
Maximum tolerated radiation dose of TheraSphere PCa
• 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
Time frame: Through 90 days post-treatment
Incidence of adverse events (AEs)
The following AEs/SAEs will be assessed in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: * Rate of any ≥ grade 3 AEs * Rate of AEs of interest, i.e., any ≥ Grade 2 GI/GU and erectile dysfunction toxicities * Rate of any treatment-emergent AEs and treatment-emergent SAEs * Rate of any treatment-related AEs and treatment-related SAEs * AEs related to non-target TheraSphere PCa distribution
Time frame: Through 5 years post-treatment (acute ≤ 90 days and late > 90 days)
Rate of success of delivering intended dose
• The ability to deliver the intended TheraSphere PCa absorbed dose (+/- 20%) to the treatment volume based on post-treatment PET derived absorbed dose.
Time frame: Immediately post-treatment
Recurrence Free Survival
• 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.
Time frame: Through 5 years post-treatment
Progression free survival (PFS)
• 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.
Time frame: Through 5 years post-treatment
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Prostate cancer specific survival
• Prostate cancer specific survival will be measured as the number of days between treatment with TheraSphere PCa and death by prostate cancer.
Time frame: Through 5 years post-treatment
Overall survival (OS)
• OS will be measured as the number of days between treatment with TheraSphere PCa and death by any cause.
Time frame: Through 5 years post-treatment
Rate of subsequent prostate anticancer treatment
• A summary table with number of subjects (%) who received subsequent definitive or systematic therapy and type of therapies received will be presented.
Time frame: Through 5 years post-treatment
Rate of histopathological recurrence
• Rate of recurrence based on histopathological assessment of prostate MR/US-fusion biopsy in patients with evidence of progression.
Time frame: Through 5 years post-treatment
Quality of Life (QoL) measured by EPIC-26
• Change from baseline measured through Expanded Prostate Cancer Index Composite (EPIC-26).
Time frame: Through 5 years post-treatment
Quality of Life (QoL) measured by MSHQ
• Change from baseline measured through Male Sexual Health Questionnaire (MSHQ).
Time frame: Through 5 years post-treatment
Quality of Life (QoL) measured by I-PSS
• Change from baseline measured through International Prostate Symptom Score (I-PSS).
Time frame: Through 5 years post-treatment
Maximum urinary flow (Qmax)
• Change from baseline
Time frame: Through 5 years post-treatment
Post-void residual (PVR) urine test
• Change from baseline
Time frame: Through 5 years post-treatment
Dose Distribution
• Dose Volume Histogram (DVH) and evaluation of D90 from post-treatment Y90 PET-MRI/CT.
Time frame: Through one-week post-treatment