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

Study Overview
=================
Brief Summary
-----------------
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. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks

Official Title
-----------------
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

Conditions
-----------------
Prostate Carcinoma, Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: Merit Medical Embospheres
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method. Receiving androgen deprivation therapy (ADT) 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostatic Artery Embolization (PAE)<br>Participants who receive PAE with Merit Medical Embospheres. | Device: Merit Medical Embospheres<br>* Prostatic Artery Embolization will performed as an outpatient procedure in Interventional Radiology. Bilateral selective pelvic angiograms will be performed to localize the prostatic arteries. Cone-beam or 3D computed tomography (CT) will be performed prior to embolization, if technically feasible and necessary. Embolization will be performed using Merit Medical Embospheres.<br>Radiation: Radiation Therapy<br>* Patients will undergo standard of care definitive radiation therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Prostate Symptom Score | Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom almost always. | At screening, Day of PAE, and 6 weeks & 12 weeks after PAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Volume Reduction after PAE | Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume. | At 12 weeks | 
| Change in American Urologic Association Score | Participants will take quality of life questionnaires including the American Urologic Association (AUA) test to assess genitourinary toxicity after PAE and radiation therapy. The AUA questionnaire asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating indicating the participant has not had a symptom at all, and 5 indicating the symptom almost always. | At 18 weeks |