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

Running, not enrolling · Not applicable

Conditions studied: Prostate, Cancer

In brief

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.

Key facts

Study ID

NCT06192758

Run by

Boston Scientific Corporation

People needed

36

Starts

2024-04-15

Expected to finish

2032-10-01

Last updated by the study team

2026-07-31

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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)
• 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

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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