Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device (NCT06192758) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
United States36 participantsStarted 2024-04-15
Plain-language 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.
Who can participate
Age range50 Years
SexMALE
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Inclusion criteria
✓. 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:
✓. cT2b-cT2c
✓. Grade Group 2 or 3
✓. PSA 10-20 ng/mL
✓. 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)
Exclusion criteria
✕. 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
What they're measuring
1
Maximum tolerated radiation dose of TheraSphere PCa
✕. 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