TheraSphere Device for Prostate Cancer

(VOYAGER Trial)

Not currently recruiting at 4 trial locations

Overseen By McAnthony Tarway

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the TheraSphere PCa device to determine its safety for treating prostate cancer confined to the prostate gland. The study explores different dose levels to identify the safest one for patients with favorable intermediate-risk prostate cancer. Men diagnosed with localized prostate cancer who have declined or are not eligible for standard treatments might be suitable candidates for this trial. Various centers in the U.S. will conduct the trial.

As an unphased trial, this study offers patients the chance to contribute to pioneering research that could lead to new treatment options.

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.

What prior data suggests that the TheraSphere PCa device is safe for prostate cancer treatment?

Research shows that TheraSphere PCa is being tested to determine the safest radiation dose for prostate cancer treatment. The VOYAGER Study examines how well patients tolerate this treatment. Since TheraSphere PCa is being tested in humans for the first time, the study closely monitors safety and any side effects.

As TheraSphere PCa is in the early testing stages for prostate cancer, complete safety information is not yet available. However, the study's increasing doses suggest that participants have tolerated initial doses well enough to explore higher ones.

Participants are placed in groups with different dose levels to carefully observe their reactions and ensure the treatment remains safe as doses increase. This careful approach helps protect patients while exploring the treatment's potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, which often involve surgery, radiation, or hormone therapy, TheraSphere PCa offers a unique approach by using tiny glass beads filled with radioactive material to target cancer cells directly. This technique, known as selective internal radiation therapy (SIRT), allows for precise delivery of high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. Researchers are excited because this method could potentially lead to more effective treatments with fewer side effects, offering a new hope for patients with prostate cancer.

What evidence suggests that the TheraSphere PCa device is effective for prostate cancer?

Research shows that TheraSphere PCa is being explored as a potential treatment for prostate cancer. It delivers precise radiation directly to cancer cells. Early results suggest this method could effectively target tumors with high doses of radiation while minimizing harm to nearby healthy tissue. Although limited information exists on its success specifically for prostate cancer, the technology uses tiny radioactive glass beads, which have shown promise in treating other cancers. This trial will test TheraSphere PCa in a dose escalation format, aiming to focus the treatment more accurately and potentially reduce side effects compared to traditional radiation therapy. As more research is conducted, researchers aim to confirm these early positive signs of its benefits. ^{1 2 5 6 7}

Who Is on the Research Team?

Mark D. Hurwitz

Principal Investigator

Westchester Medical Center

Samdeep Mouli, MD

Principal Investigator

Northwestern Medical Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• TheraSphere PCa

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.

How Is the Trial Designed?

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

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/interventional-radiology/interventional-oncology/therasphere/clinical-data/vo90yager-study.html

VOYAGER Study on Prostate Cancer with TheraSphere™ Review the details of the first-in-human, early feasibility research of the safety, accuracy, and effectiveness of TheraSphere™ PCa in prostate cancer patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06192758?tab=history&a=11

Record History | ver. 11: 2024-10-25 | NCT06192758 An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06192758/dose-escalation-study-evaluating-safety-of-therasphere-prostate-cancer-pca-device

Dose Escalation Study Evaluating Safety of TheraSphere ... The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705205/

Review of Current Treatment Intensification Strategies for ... Patients with intermediate-risk localized PCa who received RT + 4-month STADT compared with those who received RT alone showed a survival benefit. In a median ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-00281

Dose Escalation Study Evaluating Safety of TheraSphere ... The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere PCa device.

6. ctv.veeva.com ctv.veeva.com/study/first-in-human-dose-escalation-study-evaluating-safety-of-therasphere-prostate-cancer-pca-device

Dose Escalation Study Evaluating Safety of TheraSphere ... This study aims to investigate the maximum safe radiation dose of TheraSphere Prostate Cancer (PCa) device that can be delivered in patients with clinically ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06192758

Dose Escalation Study Evaluating Safety of TheraSphere ... Prostate cancer specific survival will be measured as the number of days between treatment with TheraSphere PCa and death by prostate cancer. Through 5 years ...