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

Not Applicable

Recruiting

• Conditions: Cancer; Prostate
• Interventions: Device: TheraSphere PCa

• Registration Number: NCT06192758
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Study Start: 2024-04-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-29
• Primary Completion: 2028-01
• Study Completion: 2032-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 36

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. <50% biopsy cores positive (e.g., <6 of 12 cores)

4. Staging MRI must confirm American Joint Committee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c.

5. Whole prostate gland volume ≥ 60 cc (measured on MRI)

6. International Prostate Score Symptom (I-PSS) ≤ 18

7. Estimated life expectancy of >5 years according to NCCN guideline's tools (NCCN v03.2022) who has declined or is ineligible for Standard of Care treatments (observation, active surveillance, surgery, and radiation therapies [brachytherapy/external beam radiation therapy])

8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

9. Angiographic inclusion criteria:

   • a. Type I to IV prostate artery origins on both hemiglands.1
   • b. No evidence of procedure limiting vascular abnormalities (aneurysms, stenosis, shunt, fistula, occlusion) or morphologic asymmetric single prostate artery on either side (hemigland)
   • c. Bilaterally accessible solitary prostatic arteries.
   • d. Complete perfusion of the prostate gland via a single dominant vessel for each hemigland

10. Have adequate organ and bone marrow function within 30 days prior to index procedure, as defined below:

    • a. International Normalized Ratio (INR) ≤ 1.2 (in absence of anticoagulation)
    • b. Platelets ≥ 75,000/L
    • c. GFR ≥ 40 mL/min/1.73m2
    • d. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    • e. Hemoglobin (Hgb) ≥ 9.0 g/dL (Note: the use of transfusion or other intervention to achieve adequate bone marrow function is acceptable
    • f. ALT/AST ≤ 5 x upper limit of normal (ULN)
    • g. Bilirubin ≤ 2 mg/dL

11. Patients with known Human Immunodeficiency Virus (HIV) infection are eligible with well controlled HIV infection, no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells/uL

Exclusion Criteria

1. Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)

2. Histological evidence of intraductal features

3. Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization [PAE], transurethral resection of the prostate [TURP] or previous/ planned hormonal therapy

4. History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter

5. Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder

6. Prior significant rectal surgery (haemorrhoidectomy is acceptable)

7. Prior invasive malignancy unless disease free for a minimum of 3 years. Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease

8. Hip prosthesis

9. Medical contraindication to undergo contrast-enhanced angiography, CT scan and magnetic resonance imaging (MRI), or arterial catheterization, or known history of hypersensitivity reactions to iodinated and gadolinium-based contrast product

10. Angiographic exclusion criteria:

    • a. Perfusion to tissues outside the Planning Target Volume (PTV) that cannot be corrected by placement of the catheter distal to collateral vessels or the application of standard angiographic techniques, such as coil embolization
    • b. Type V prostatic artery origin on either side

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TheraSphere PCa Dose Escalation	TheraSphere PCa	Participants will be treated in cohorts of three across three sequential dose levels: * Dose Level 1 (or starting dose) = 175 Gy; however, a provisional lower dose level, Dose Level -1 = 150 Gy, may be utilized in case de-escalation is warranted at Dose Level 1. * Dose Level 2 = 200 Gy * Dose Level 3 = 225 Gy

Primary Outcome Measures

Name	Time	Method
Maximum tolerated radiation dose of TheraSphere PCa	Through 90 days post-treatment	• 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

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL) measured by EPIC-26	Through 5 years post-treatment	• Change from baseline measured through Expanded Prostate Cancer Index Composite (EPIC-26).
Incidence of adverse events (AEs)	Through 5 years post-treatment (acute ≤ 90 days and late > 90 days)	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
Rate of success of delivering intended dose	Immediately post-treatment	• The ability to deliver the intended TheraSphere PCa absorbed dose (+/- 20%) to the treatment volume based on post-treatment PET derived absorbed dose.
Progression free survival (PFS)	Through 5 years post-treatment	• 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.
Prostate cancer specific survival	Through 5 years post-treatment	• Prostate cancer specific survival will be measured as the number of days between treatment with TheraSphere PCa and death by prostate cancer.
Post-void residual (PVR) urine test	Through 5 years post-treatment	• Change from baseline
Recurrence Free Survival	Through 5 years post-treatment	• 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.
Overall survival (OS)	Through 5 years post-treatment	• OS will be measured as the number of days between treatment with TheraSphere PCa and death by any cause.
Rate of subsequent prostate anticancer treatment	Through 5 years post-treatment	• A summary table with number of subjects (%) who received subsequent definitive or systematic therapy and type of therapies received will be presented.
Rate of histopathological recurrence	Through 5 years post-treatment	• Rate of recurrence based on histopathological assessment of prostate MR/US-fusion biopsy in patients with evidence of progression.
Quality of Life (QoL) measured by MSHQ	Through 5 years post-treatment	• Change from baseline measured through Male Sexual Health Questionnaire (MSHQ).
Quality of Life (QoL) measured by I-PSS	Through 5 years post-treatment	• Change from baseline measured through International Prostate Symptom Score (I-PSS).
Maximum urinary flow (Qmax)	Through 5 years post-treatment	• Change from baseline
Dose Distribution	Through one-week post-treatment	• Dose Volume Histogram (DVH) and evaluation of D90 from post-treatment Y90 PET-MRI/CT.

Trial Locations

Locations (5)

Ronald Reagan UCLA Medical Center (UCLA Health, Los Angeles); 🇺🇸 Los Angeles, California, United States

University of Miami (Sylvester Comprehensive Cancer Center); 🇺🇸 Miami, Florida, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States