Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization

Korábbi kezelés

• Receiving androgen deprivation therapy (ADT)
• Receiving any investigational agents for the explicit purpose of prostatic size reduction
• Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of definitive radiation therapy
• History of severe allergic reaction to intravenous contrast media (iodinated and gadolinium- based) or any agents used during the PAE; patient cannot be medicated against allergic reaction prior to PAE.
• Prior transurethral resection of the prostate (TURP) within 2 years

Más betegség

• Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
• Active urinary tract infection (UTI)

Egyéb

• Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
• Active cystolithiasis or prostatitis
• Inability to have multi-parametric magnetic resonance imaging (mpMRI)
• Prostate size greater than or equal to150 grams
• Vulnerable subjects (e.g., inmates and developmentally delayed adults) who are subjects for whom the study may be unsafe or whose rights may be violated with enrollment.

• Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade groups 1 and 2) who are eligible for and who select XRT as their cancer management method.
• Ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy.
• Ability to understand and the willingness to sign a written informed consent document
• Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans
• American Urologic Association (AUA) or International Prostate Symptom Score (IPSS) Score ≥ 15
• Normal organ and marrow function as defined in protocol