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

NCT ID: NCT06192758

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2032-10-31

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.

Conditions

Prostate; Cancer

Keywords

Radiation; TheraSphere; Y90; Yttrium-90; Glass; Microspheres

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TheraSphere PCa Dose Escalation

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

Group Type: EXPERIMENTAL

TheraSphere PCa

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

TheraSphere PCa - Yttrium-90 Glass Microspheres

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. <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

• 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

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samdeep Mouli, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Northwestern Medical Hospital

Mark Hurwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Westchester Medical Center

Locations

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

Countries

United States

References

Mouli SK, Raiter S, Harris K, Mylarapu A, Burks M, Li W, Gordon AC, Khan A, Matsumoto M, Bailey KL, Pasciak AS, Manupipatpong S, Weiss CR, Casalino D, Miller FH, Gates VL, Hohlastos E, Lewandowski RJ, Kim DH, Dreher MR, Salem R. Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation. J Vasc Interv Radiol. 2021 Aug;32(8):1103-1112.e12. doi: 10.1016/j.jvir.2021.01.282. Epub 2021 Apr 9.

Reference Type: BACKGROUND

PMID: 33839262 (View on PubMed)

Yuan Y, Lin R, Li D, Nie L, Warren KE. Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clin Cancer Res. 2018 Oct 15;24(20):4921-4930. doi: 10.1158/1078-0432.CCR-18-0246. Epub 2018 May 16.

Reference Type: BACKGROUND

PMID: 29769209 (View on PubMed)

Other Identifiers

S2493

Identifier Type: -

Identifier Source: org_study_id