Evaluating the safety of TheraSphere device for prostate cancer treatment
An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer
This study is testing whether the TheraSphere device is safe for treating localized prostate cancer by delivering targeted radiation directly to the tumor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06192758 on ClinicalTrials.gov |
What this trial studies
The VOYAGER Study is an interventional, non-randomized, single-arm trial aimed at assessing the safety of the TheraSphere device in patients with clinically localized prostate cancer. This study utilizes Yttrium-90 glass microspheres, which are injected into the blood vessels feeding the tumor, allowing for targeted radiation therapy that minimizes exposure to surrounding healthy tissues. Participants will undergo a series of imaging assessments and follow-up visits over a five-year period to evaluate the safety profile, technical feasibility, efficacy, and quality of life metrics associated with the treatment. The study will determine the maximum safe radiation dose that can be delivered to patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with favorable intermediate-risk clinically localized prostate cancer who meet specific histologic and staging criteria.
Not a fit: Patients with advanced prostate cancer or those who do not meet the eligibility criteria may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, targeted therapy option for patients with localized prostate cancer, potentially improving outcomes and quality of life.
How similar studies have performed: Other studies utilizing targeted radiation therapies have shown promise, indicating that this approach may be effective, although this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. 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.
2. 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.
3. 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):
1. cT2b-cT2c
2. Grade Group 2 or 3
3. PSA 10-20 ng/mL
* ii. Grade Group 1 or 2
* iii. \<50% biopsy cores positive (e.g., \<6 of 12 cores)
4. Staging MRI must confirm American Joint Committee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c.
5. Whole prostate gland volume ≥ 60 cc (measured on MRI)
6. International Prostate Score Symptom (I-PSS) ≤ 18
7. 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 \[brachytherapy/external beam radiation therapy\])
8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
9. 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
10. 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
11. 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
Exclusion Criteria:
1. Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)
2. Histological evidence of intraductal features
3. Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization \[PAE\], transurethral resection of the prostate \[TURP\] or previous/ planned hormonal therapy
4. History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter
5. Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder
6. Prior significant rectal surgery (haemorrhoidectomy is acceptable)
7. 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
8. Hip prosthesis
9. 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
10. 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
Where this trial is running
Los Angeles, California and 4 other locations
- Ronald Reagan UCLA Medical Center (UCLA Health, Los Angeles) — Los Angeles, California, United States (Not_yet_recruiting)
- University of Miami (Sylvester Comprehensive Cancer Center) — Miami, Florida, United States (Not_yet_recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Not_yet_recruiting)
- Weill Cornell Medicine — New York, New York, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Samdeep Mouli, M.D., M.S. — Northwestern Medical Hospital
- Study coordinator: McAnthony Tarway
- Email: mcanthony.tarway@bsci.com
- Phone: 615-580-1320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.