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

NCT06192758 | Active Not Recruiting DMC FDA Device

• 1 other identifier: S2493
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate; Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Through 90 days post-treatment

Secondary Outcomes (14)

• Incidence of adverse events (AEs)

  Through 5 years post-treatment (acute ≤ 90 days and late > 90 days)

• Rate of success of delivering intended dose

  Immediately post-treatment

• Recurrence Free Survival

  Through 5 years post-treatment

• Progression free survival (PFS)

  Through 5 years post-treatment

• Prostate cancer specific survival

  Through 5 years post-treatment

Other Outcomes (1)

• Prostatic imaging assessment

  Through 5 years post-treatment

Study Arms (1)

TheraSphere PCa Dose Escalation

EXPERIMENTAL

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

Device: TheraSphere PCa

Interventions

TheraSphere PCa 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).

Also known as: TheraSphere PCa - Yttrium-90 Glass Microspheres

TheraSphere PCa Dose Escalation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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):
• cT2b-cT2c
• Grade Group 2 or 3
• PSA 10-20 ng/mL
• ii. Grade Group 1 or 2
• iii. \<50% biopsy cores positive (e.g., \<6 of 12 cores)
• Staging MRI must confirm American Joint Committee 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 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 \[brachytherapy/external beam radiation therapy\])
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

You may not qualify if:

• Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)
• Histological evidence of intraductal features
• Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization \[PAE\], transurethral resection of the prostate \[TURP\] or previous/ planned hormonal therapy
• History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter
• Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder
• Prior significant rectal surgery (haemorrhoidectomy is acceptable)
• 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
• Hip prosthesis
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• 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.

  PMID: 33839262 BACKGROUND

• 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.

  PMID: 29769209 BACKGROUND

• Meiselman S, Thomas MA, Giardina JD, Zheleznyak A, Thorek DLJ, Malone CD. Advances in Radioembolization for Liver Cancer. J Vasc Interv Radiol. 2025 Dec;36(12):1876-1881. doi: 10.1016/j.jvir.2025.07.018.

  PMID: 41276366 DERIVED

MeSH Terms

Conditions

Neoplasms; Chromosome 2q32-Q33 Deletion Syndrome

Study Officials

• Samdeep Mouli, M.D., M.S.

  Northwestern Medical Hospital

  PRINCIPAL INVESTIGATOR

• Mark Hurwitz, MD

  Westchester Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be treated in cohorts at three sequential target absorbed radiation dose levels, where the dose level for the next cohort will be determined by a prespecified decision tree for escalation/de-escalation, according to the accelerated Time-to-Event Bayesian Optimal Interval Design (TITE-BOIN) approach. * Cohort size = 3 subjects * ≤15 subjects (or 5 cohorts) will be treated at any single dose level. ≤ 36 subjects (or 12 cohorts) will be treated in total across all doses. If no dose limiting toxicities are observed at any dose level, a minimum of 21 subjects will be treated

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 5, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)