ProstateVOYAGERNCT06192758
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
A study testing TheraSphere PCa in people with Prostate and Cancer, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- What is being tested?
- TheraSphere PCa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has ability to comprehend and willingness to sign and date the IRB-approved study informed consent form (ICF), and to comply with the study testing, procedures, and follow-up schedule.
- Histologic confirmation of adenocarcinoma of the prostate by MR-fusion biopsy. Referral biopsy for eligibility must be completed between 180 days and 6 weeks prior to mapping procedure.
- Subject with favorable intermediate risk clinically localized prostate cancer defined per NCCN Guidelines version 3.2022 as follows:
- Favorable intermediate-risk has all the following:
- i. One Intermediate Risk Factor (IRF):
- cT2b-cT2c
Show all 29Show fewer
- Grade Group 2 or 3
- PSA 10-20 ng/mL
- ii. Grade Group 1 or 2
- iii. <50% biopsy cores positive (e.g., <6 of 12 cores)
- Staging MRI must confirm American Joint Committee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c.
- Whole prostate gland volume ≥ 60 cc (measured on MRI)
- International Prostate Score Symptom (I-PSS) ≤ 18
- Estimated life expectancy of >5 years according to NCCN guideline's tools (NCCN v03.2022) who has declined or is ineligible for Standard of Care treatments (observation, active surveillance, surgery, and radiation therapies [brachytherapy/external beam radiation therapy])
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Angiographic inclusion criteria:
- a. Type I to IV prostate artery origins on both hemiglands.1
- b. No evidence of procedure limiting vascular abnormalities (aneurysms, stenosis, shunt, fistula, occlusion) or morphologic asymmetric single prostate artery on either side (hemigland)
- c. Bilaterally accessible solitary prostatic arteries.
- d. Complete perfusion of the prostate gland via a single dominant vessel for each hemigland
- Have adequate organ and bone marrow function within 30 days prior to index procedure, as defined below:
- a. International Normalized Ratio (INR) ≤ 1.2 (in absence of anticoagulation)
- b. Platelets ≥ 75,000/L
- c. GFR ≥ 40 mL/min/1.73m2
- d. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- e. Hemoglobin (Hgb) ≥ 9.0 g/dL (Note: the use of transfusion or other intervention to achieve adequate bone marrow function is acceptable
- f. ALT/AST ≤ 5 x upper limit of normal (ULN)
- g. Bilirubin ≤ 2 mg/dL
- Patients with known Human Immunodeficiency Virus (HIV) infection are eligible with well controlled HIV infection, no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
Who cannot join
- Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)
- Histological evidence of intraductal features
- Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization [PAE], transurethral resection of the prostate [TURP] or previous/ planned hormonal therapy
- History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter
- Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder
- Prior significant rectal surgery (haemorrhoidectomy is acceptable)
Show all 12Show fewer
- Prior invasive malignancy unless disease free for a minimum of 3 years. Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease
- Hip prosthesis
- 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
- Angiographic exclusion criteria:
- a. Perfusion to tissues outside the Planning Target Volume (PTV) that cannot be corrected by placement of the catheter distal to collateral vessels or the application of standard angiographic techniques, such as coil embolization
- b. Type V prostatic artery origin on either side
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer
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.
Read the detailed description
TheraSphere™ Y-90 Glass Microspheres are a targeted cancer therapy consisting of tiny glass beads containing radioactive Yttrium-90 (Y-90), which are injected directly into the blood vessel feeding the tumor through a microcatheter using advanced imaging guidance. The glass microspheres enter the tumor's blood supply, lodge within the blood vessels feeding the tumor, and release radiation to the tumor. The radiation works to destroy the tumor cells from within, thus limiting radiation exposure to surrounding normal tissues, a process referred to as selective internal radiation therapy (SIRT).
This study aims to investigate the maximum safe radiation dose of TheraSphere Prostate Cancer (PCa) device that can be delivered in patients with clinically localized prostate cancer. The study will also evaluate the full safety profile, technical feasibility, efficacy, and quality of life metrics of the TheraSphere PCa device.
Participants will be asked to complete the following:
- At least two image-guided visits, including a mapping assessment (without Technetium Tc albumin aggregated [Tc-MAA]) prior to treatment
- One treatment visit, including image-guided assessments
- Fifteen post-treatment follow-up visits for a total of approximately 20 visits over the 5-year study period
Note: the VOYAGER Study is a staged investigational device exemption (IDE) study; therefore, the full enrollment of 21 to 36 subjects is subject to FDA approval following safety review of the first 10 subjects enrolled.
- Being tested
- TheraSphere PCa
- Keywords
- Radiation, TheraSphere, Y90, Yttrium-90, Glass, Microspheres
- Medical subject headings
- Neoplasms, Chromosome 2q32-Q33 Deletion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere PCaDevice
Also called TheraSphere PCa - Yttrium-90 Glass Microspheres
Single session treatment of TheraSphere PCa - Yttrium-90 Glass Microspheres for the treatment of prostate cancer. Dose vials will be available in activity ranging from 0.1 GBq (2.7 mCi) to 3 GBq (81 mCi).
| Study group | Role | What they receive |
|---|---|---|
| TheraSphere PCa Dose Escalation | Experimental | 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 Receives: Device: TheraSphere PCa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated radiation dose of TheraSphere PCa
- The Maximum Tolerated Dose (MTD) of Yttrium-90 Glass Microspheres (TheraSphere™ PCa) is based on rate of dose limiting toxicity (DLT) through 90 days, defined as any ≥ grade 3 adverse event (AE) according to CTCAE v.5
Measured: Through 90 days post-treatment
Secondary outcomes (14)
Incidence of adverse events (AEs)
The following AEs/SAEs will be assessed in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0:
- Rate of any ≥ grade 3 AEs
- Rate of AEs of interest, i.e., any ≥ Grade 2 GI/GU and erectile dysfunction toxicities
- Rate of any treatment-emergent AEs and treatment-emergent SAEs
- Rate of any treatment-related AEs and treatment-related SAEs
- AEs related to non-target TheraSphere PCa distribution
Measured: Through 5 years post-treatment (acute ≤ 90 days and late > 90 days)
Rate of success of delivering intended dose
- The ability to deliver the intended TheraSphere PCa absorbed dose (+/- 20%) to the treatment volume based on post-treatment PET derived absorbed dose.
Measured: Immediately post-treatment
Recurrence Free Survival
- Biochemical Recurrence Free Survival (bRFS) based on PSA according to the Phoenix criteria (RTOG-ASTRO definition). Biochemical recurrence of prostate cancer after curative treatment is defined as a PSA rise of ≥ 2 ng/mL above the post-treatment nadir.
Measured: Through 5 years post-treatment
Progression free survival (PFS)
- Progression free survival (PFS) and local progression free survival (LPFS), defined as time from inclusion until one of the following events, whichever comes first: biochemical progression (Phoenix criteria) or clinical progression.
Measured: Through 5 years post-treatment
Prostate cancer specific survival
- Prostate cancer specific survival will be measured as the number of days between treatment with TheraSphere PCa and death by prostate cancer.
Measured: Through 5 years post-treatment
Overall survival (OS)
- OS will be measured as the number of days between treatment with TheraSphere PCa and death by any cause.
Measured: Through 5 years post-treatment
Rate of subsequent prostate anticancer treatment
- A summary table with number of subjects (%) who received subsequent definitive or systematic therapy and type of therapies received will be presented.
Measured: Through 5 years post-treatment
Rate of histopathological recurrence
- Rate of recurrence based on histopathological assessment of prostate MR/US-fusion biopsy in patients with evidence of progression.
Measured: Through 5 years post-treatment
Quality of Life (QoL) measured by EPIC-26
- Change from baseline measured through Expanded Prostate Cancer Index Composite (EPIC-26).
Measured: Through 5 years post-treatment
Quality of Life (QoL) measured by MSHQ
- Change from baseline measured through Male Sexual Health Questionnaire (MSHQ).
Measured: Through 5 years post-treatment
Quality of Life (QoL) measured by I-PSS
- Change from baseline measured through International Prostate Symptom Score (I-PSS).
Measured: Through 5 years post-treatment
Maximum urinary flow (Qmax)
- Change from baseline
Measured: Through 5 years post-treatment
Post-void residual (PVR) urine test
- Change from baseline
Measured: Through 5 years post-treatment
Dose Distribution
- Dose Volume Histogram (DVH) and evaluation of D90 from post-treatment Y90 PET-MRI/CT.
Measured: Through one-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Apr 2024
- Primary completionJan 2028 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be treated in cohorts at three sequential target absorbed radiation dose levels, where the dose level for the next cohort will be determined by a prespecified decision tree for escalation/de-escalation, according to the accelerated Time-to-Event Bayesian Optimal Interval Design (TITE-BOIN) approach. * Cohort size = 3 subjects * ≤15 subjects (or 5 cohorts) will be treated at any single dose level. ≤ 36 subjects (or 12 cohorts) will be treated in total across all doses. If no dose limiting toxicities are observed at any dose level, a minimum of 21 subjects will be treated
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samdeep Mouli, M.D., M.S., Principal investigator, Northwestern Medical HospitalMark Hurwitz, MD, Principal investigator, Westchester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192758
- Sponsor's protocol ID
- S2493
- Acronym
- VOYAGER
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mouli SK, Raiter S, Harris K, Mylarapu A, Burks M, Li W, Gordon AC, Khan A, Matsumoto M, Bailey KL, Pasciak AS, Manupipatpong S, Weiss CR, Casalino D, Miller FH, Gates VL, Hohlastos E, Lewandowski RJ, Kim DH, Dreher MR, Salem R. Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation. J Vasc Interv Radiol. 2021 Aug;32(8):1103-1112.e12. doi: 10.1016/j.jvir.2021.01.282. Epub 2021 Apr 9.
PubMed 33839262Yuan Y, Lin R, Li D, Nie L, Warren KE. Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clin Cancer Res. 2018 Oct 15;24(20):4921-4930. doi: 10.1158/1078-0432.CCR-18-0246. Epub 2018 May 16.
PubMed 29769209Meiselman S, Thomas MA, Giardina JD, Zheleznyak A, Thorek DLJ, Malone CD. Advances in Radioembolization for Liver Cancer. J Vasc Interv Radiol. 2025 Dec;36(12):1876-1881. doi: 10.1016/j.jvir.2025.07.018.
PubMed 41276366
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06192758
- Acronym / sponsor ID
- VOYAGER / S2493
- Keywords
- Radiation, TheraSphere, Y90, Yttrium-90, Glass, Microspheres
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TheraSphere™ Y-90 Glass Microspheres are a targeted cancer therapy consisting of tiny glass beads containing radioactive Yttrium-90 (Y-90), which are injected directly into the blood vessel feeding the tumor through a microcatheter using advanced imaging guidance. The glass microspheres enter the tumor's blood supply, lodge within the blood vessels feeding the tumor, and release radiation to the tumor. The radiation works to destroy the tumor cells from within, thus limiting radiation exposure to surrounding normal tissues, a process referred to as selective internal radiation therapy (SIRT).
This study aims to investigate the maximum safe radiation dose of TheraSphere Prostate Cancer (PCa) device that can be delivered in patients with clinically localized prostate cancer. The study will also evaluate the full safety profile, technical feasibility, efficacy, and quality of life metrics of the TheraSphere PCa device.
Participants will be asked to complete the following:
- At least two image-guided visits, including a mapping assessment (without Technetium Tc albumin aggregated [Tc-MAA]) prior to treatment
- One treatment visit, including image-guided assessments
- Fifteen post-treatment follow-up visits for a total of approximately 20 visits over the 5-year study period
Note: the VOYAGER Study is a staged investigational device exemption (IDE) study; therefore, the full enrollment of 21 to 36 subjects is subject to FDA approval following safety review of the first 10 subjects enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be treated in cohorts at three sequential target absorbed radiation dose levels, where the dose level for the next cohort will be determined by a prespecified decision tree for escalation/de-escalation, according to the accelerated Time-to-Event Bayesian Optimal Interval Design (TITE-BOIN) approach. * Cohort size = 3 subjects * ≤15 subjects (or 5 cohorts) will be treated at any single dose level. ≤ 36 subjects (or 12 cohorts) will be treated in total across all doses. If no dose limiting toxicities are observed at any dose level, a minimum of 21 subjects will be treated
| Arm | Type | Receives |
|---|---|---|
| TheraSphere PCa Dose Escalation | Experimental | Device: TheraSphere PCaParticipants 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 may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subject has ability to comprehend and willingness to sign and date the IRB-approved study informed consent form (ICF), and to comply with the study testing, procedures, and follow-up schedule.
- Histologic confirmation of adenocarcinoma of the prostate by MR-fusion biopsy. Referral biopsy for eligibility must be completed between 180 days and 6 weeks prior to mapping procedure.
- Subject with favorable intermediate risk clinically localized prostate cancer defined per NCCN Guidelines version 3.2022 as follows:
- Staging MRI must confirm American Joint Committee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c.
- Whole prostate gland volume ≥ 60 cc (measured on MRI)
Key exclusion criteria (12 listed)
- Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)
- Histological evidence of intraductal features
- Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization [PAE], transurethral resection of the prostate [TURP] or previous/ planned hormonal therapy
- History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter
- Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphere PCaAlso: TheraSphere PCa - Yttrium-90 Glass MicrospheresSingle session treatment of TheraSphere PCa - Yttrium-90 Glass Microspheres for the treatment of prostate cancer. Dose vials will be available in activity ranging from 0.1 GBq (2.7 mCi) to 3 GBq (81 mCi). | Device | TheraSphere PCa Dose Escalation |
Primary outcome
Maximum tolerated radiation dose of TheraSphere PCa
Time frame: Through 90 days post-treatment
• The Maximum Tolerated Dose (MTD) of Yttrium-90 Glass Microspheres (TheraSphere™ PCa) is based on rate of dose limiting toxicity (DLT) through 90 days, defined as any ≥ grade 3 adverse event (AE) according to CTCAE v.5
14 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Through 5 years post-treatment (acute ≤ 90 days and late > 90 days)
Rate of success of delivering intended dose
Time frame: Immediately post-treatment
Recurrence Free Survival
Time frame: Through 5 years post-treatment
Progression free survival (PFS)
Time frame: Through 5 years post-treatment
Prostate cancer specific survival
Time frame: Through 5 years post-treatment
Overall survival (OS)
Time frame: Through 5 years post-treatment
Rate of subsequent prostate anticancer treatment
Time frame: Through 5 years post-treatment
Rate of histopathological recurrence
Time frame: Through 5 years post-treatment
Quality of Life (QoL) measured by EPIC-26
Time frame: Through 5 years post-treatment
Quality of Life (QoL) measured by MSHQ
Time frame: Through 5 years post-treatment
Quality of Life (QoL) measured by I-PSS
Time frame: Through 5 years post-treatment
Maximum urinary flow (Qmax)
Time frame: Through 5 years post-treatment
Post-void residual (PVR) urine test
Time frame: Through 5 years post-treatment
Dose Distribution
Time frame: Through one-week post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 33839262Mouli SK, Raiter S, Harris K, Mylarapu A, Burks M, Li W, Gordon AC, Khan A, Matsumoto M, Bailey KL, Pasciak AS, Manupipatpong S, Weiss CR, Casalino D, Miller FH, Gates VL, Hohlastos E, Lewandowski RJ, Kim DH, Dreher MR, Salem R. Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation. J Vasc Interv Radiol. 2021 Aug;32(8):1103-1112.e12. doi: 10.1016/j.jvir.2021.01.282. Epub 2021 Apr 9.
- Background: PubMed 29769209Yuan Y, Lin R, Li D, Nie L, Warren KE. Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clin Cancer Res. 2018 Oct 15;24(20):4921-4930. doi: 10.1158/1078-0432.CCR-18-0246. Epub 2018 May 16.
- Derived from this study: PubMed 41276366Meiselman S, Thomas MA, Giardina JD, Zheleznyak A, Thorek DLJ, Malone CD. Advances in Radioembolization for Liver Cancer. J Vasc Interv Radiol. 2025 Dec;36(12):1876-1881. doi: 10.1016/j.jvir.2025.07.018.
- Individual participant dataSharing planned: No
Related trials for Prostate
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samdeep Mouli, M.D., M.S. principal investigator
Northwestern Medical Hospital
Mark Hurwitz, MD principal investigator
Westchester Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere PCa in people with Prostate and Cancer, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated radiation dose of TheraSphere PCa (time frame: Through 90 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192758, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.