TheraSphere Device for Prostate Cancer

(VOYAGER Trial)

Recruiting at4 trial locations

Overseen by Mark D. Hurwitz

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Scientific Corporation

Disqualifiers: Metastases, Intraductal features, Crohn's, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Mark D. Hurwitz

Principal Investigator

Westchester Medical Center

Samdeep Mouli, MD

Principal Investigator

Northwestern Medical Hospital

Eligibility Criteria

This trial is for patients with clinically localized prostate cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and have no conditions that could interfere with the study.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My prostate cancer is at an intermediate stage, according to NCCN guidelines.

I have HIV with no AIDS complications and my CD4+ count is above 350.

Exclusion Criteria

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

I have been cancer-free for at least 3 years, except for certain skin cancers or localized cancers that were treated.

I have a history of Crohn's, ulcerative colitis, or ataxia telangiectasia, or currently have visible blood in my urine or a urinary catheter.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Treatment Imaging

Participants undergo at least two image-guided visits, including a mapping assessment prior to treatment

1-2 weeks

2 visits (in-person)

Treatment

Participants receive the TheraSphere PCa device treatment with image-guided assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, efficacy, and quality of life metrics post-treatment

5 years

15 visits (in-person)

Treatment Details

Interventions

• TheraSphere PCa (Brachytherapy)

Trial Overview The VOYAGER Study is testing the TheraSphere PCa device's safety in treating localized prostate cancer. It's a first-in-human study where all participants receive escalating doses of this new treatment.

Participant Groups

Group I: TheraSphere PCa Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology