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TheraSphere™ Glass Microspheres

VO90YAGER study

CAUTION: TheraSphere PCa is an investigational device limited by United States law for investigational use only. It is not an approved treatment for prostate cancer and is not for sale. 

VO90YAGER study overview

The VO90YAGER Study is a first-in-human, early feasibility study assessing the use of TheraSphere PCa Y-90 Glass Microspheres in patients with localized prostate cancer (PCa). The purpose of the VO90YAGER Study is to evaluate the safety of using TheraSphere PCa to treat prostate cancer patients. Additionally, the study will evaluate the accuracy and effectiveness of the treatment.

CAUTION: In the U.S. TheraSphere™ PCa is under an investigational device exemption for treatment of patients with prostate cancer and limited by Federal (or US) law to investigational use. The safety and effectiveness for this treatment has not been established.

Voyager study logo

Study design

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Localized prostate cancer (PCa)

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Up to 36 patients

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Up to 5 sites

Patient criteria

  • Age ≥ 50 years old

  • Favorable intermediate risk clinically localized prostate cancer

  • Adequate vascular anatomy to allow safe delivery of the TheraSphere PCa treatment

Treatment

Prior to the TheraSphere PCa administration procedure, the patient will need to have some imaging tests (MRI and CT scans) to make sure they are eligible for the VO90YAGER trial and determine how much TheraSphere PCa will be needed to treat the patient’s prostate. 

On the day of treatment, TheraSphere PCa will be administered in a single treatment via a selective transcatheter arterial injection in each hemigland of the prostate.

Primary outcome measures

To investigate the Maximum Tolerated Dose of TheraSphere PCa across a range of absorbed radiation doses administered by selective transcatheter arterial injection in patients with clinically localized prostate cancer. 

  • E.g., to evaluate the safety of using TheraSphere PCa to treat prostate cancer patients.

Secondary outcome measures

To evaluate the full safety profile, technical feasibility, efficacy, and Quality of Life metrics of the TheraSphere PCa technology administered by selective transcatheter arterial injection in patients with clinically localized prostate cancer.

  • E.g., to evaluate the accuracy and effectiveness of the TheraSphere PCa treatment.


Referring physician information

Dr Mouli.

Northwestern Memorial Hospital

City: Chicago, IL 

Principal Investigator (Interventional Radiologist):  Samdeep Mouli, MD  

Co-Investigator (Urologic Oncologist):  Ashley Ross, MD, PhD 

Co- Investigator (Radiation Oncologist):  Sean Sachdev, MD 

Contact (Research Manager): Carlene Liana del Castillo 

Email:  carlene.castillo@northwestern.edu


Boston Scientific (Sponsor) Clinical Trial Contacts

For more information about the VO90YAGER study, please contact a Boston Scientific clinical trial personnel via the trial mailbox at VO90YAGERStudy@bsci.com, or directly as follows: 

TheraSphere is a registered trademark of Theragenics Corporation, used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.