A Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients with Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment.
Primary Objective: To assess the clinical efficacy of PAE on LUTS
(i) To assess prostate volume reduction after PAE.
(ii) To assess acute GU toxicity after PAE
(i) To assess for clinical or imaging signs of disease progression after PAE before definitive radiotherapy
(ii) To assess effects of PAE on treatment planning
Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Grade groups 1 and 2 ) and eligible for radiation therapy.
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
Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
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
Active urinary tract infection (UTI)
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.
Active cystolithiasis or prostatitis
Inability to have multi-parametric magnetic resonance imaging (mpMRI)
Prior transurethral resection of the prostate (TURP) within 2 years
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
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub