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Brachytherapy

TheraSphere Device for Prostate Cancer (VOYAGER Trial)

N/A

Waitlist Available

Led By Samdeep Mouli, M.D., M.S.

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject with favorable intermediate risk clinically localized prostate cancer as defined per NCCN Guidelines version 3.2022

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

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called TheraSphere PCa in patients with prostate cancer. The main goal of the study is to determine if the device is safe to use in patients. The trial

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a dose escalation study for a new device, specific side effects are being determined. Generally, potential risks may include discomfort at the treatment site, urinary issues, or other complications related to prostate treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My breast cancer is in an early stage according to my MRI results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cancer has spread beyond its original location.

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I currently have a urinary tract infection, prostate issues, or bladder control problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated radiation dose of TheraSphere PCa

Secondary study objectives

Dose Distribution

Incidence of adverse events (AEs)

Maximum urinary flow (Qmax)

+11 more

Other study objectives

Prostatic imaging assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TheraSphere PCa Dose EscalationExperimental Treatment1 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

0 / 7Eligibility criteria met