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Brachytherapy

TheraSphere PCa Dose Escalation for Prostate (VOYAGER Trial)

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years post-treatment

Awards & highlights

VOYAGER Trial 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.Check my eligibility

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.See study design

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.

VOYAGER Trial 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.

VOYAGER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated radiation dose of TheraSphere PCa

Secondary outcome measures

Dose Distribution

Incidence of adverse events (AEs)

Maximum urinary flow (Qmax)

+11 more

Other outcome measures

Prostatic imaging assessment

VOYAGER 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

720 Previous Clinical Trials

932,986 Total Patients Enrolled

Samdeep Mouli, M.D., M.S.Principal InvestigatorNorthwestern Medical Hospital

Mark Hurwitz, MDPrincipal InvestigatorWestchester Medical Center

3 Previous Clinical Trials

318 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this study?

"As per the information provided on clinicaltrials.gov, this specific study is currently not accepting new participants. Its initial posting date was January 1st, 2024, and it was last updated on December 21st, 2023. However, please note that there are currently a total of 1710 other studies actively seeking eligible individuals to participate in various medical research endeavors."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"This clinical trial is being conducted at several prestigious locations, including the University of Miami (Sylvester Comprehensive Cancer Center) in Miami, Florida; Ronald Reagan UCLA Medical Center (UCLA Health) in Los Angeles, California; and Mount Sinai Hospital in New york, New York. Additionally, there are five other sites where the study is also taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "First In Human Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06192758.

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