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

Phase 2

Recruiting

• Conditions: Prostate Carcinoma; Benign Prostatic Hyperplasia

• Registration Number: NCT04879940
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-5-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

Inclusion Criteria:<br><br> - Histologically or cytologically confirmed prostate adenocarcinoma in the very low or<br> low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade<br> groups 1 and 2) who are eligible for and who select XRT as their cancer management<br> method.<br><br> - Ability to receive prostatic artery embolization within 6-12 weeks of definitive<br> radiation therapy.<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document<br><br> - Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans<br><br> - American Urologic Association (AUA) or International Prostate Symptom Score (IPSS)<br> Score = 15<br><br> - Normal organ and marrow function as defined in protocol<br><br>Exclusion Criteria:<br><br> - Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their<br> cancer management method.<br><br> - Receiving androgen deprivation therapy (ADT)<br><br> - Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk<br> localized PCa (Gleason Grade Groups 4 and 5)<br><br> - Receiving any investigational agents for the explicit purpose of prostatic size<br> reduction<br><br> - Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of<br> definitive radiation therapy<br><br> - Active urinary tract infection (UTI)<br><br> - History of severe allergic reaction to intravenous contrast media (iodinated and<br> gadolinium- based) or any agents used during the PAE; patient cannot be medicated<br> against allergic reaction prior to PAE.<br><br> - Active cystolithiasis or prostatitis<br><br> - Inability to have multi-parametric magnetic resonance imaging (mpMRI)<br><br> - Prior transurethral resection of the prostate (TURP) within 2 years<br><br> - Prostate size greater than or equal to150 grams<br><br> - Vulnerable subjects (e.g., inmates and developmentally delayed adults) who are<br> subjects for whom the study may be unsafe or whose rights may be violated with<br> enrollment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in International Prostate Symptom Score

Secondary Outcome Measures

Name	Time	Method
Prostate Volume Reduction after PAE;Change in American Urologic Association Score