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

Eligibility 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
• 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