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

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. 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

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia; Prostate Carcinoma
• Intervention / Treatment: Device: Merit Medical Embospheres; Radiation: Radiation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Scott Hagen; Phone Number: 813-745-0683; Email: scott.hagen@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Brandon Manley, MD
      • Sub-Investigator: Michael Poch, MD
      • Principal Investigator: Nainesh S Parikh, MD, MBA
      • Sub-Investigator: Julio Pow Sang, MD
      • Sub-Investigator: Kosj Yamoah, MD, PhD
      • Sub-Investigator: Javier F Torres-Roca, MD
      • Sub-Investigator: Peter A Johnstone, MD
      • Sub-Investigator: Daniel Grass, MD
      • Contact: Scott Hagen; Phone Number: 813-745-0683; Email: scott.hagen@moffitt.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prostatic Artery Embolization (PAE); Participants who receive PAE with Merit Medical Embospheres.

Device: Merit Medical Embospheres; 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.; Radiation: Radiation Therapy; Patients will undergo standard of care definitive radiation therapy.

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Nainesh S Parikh, MD, MBA, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Carcinoma; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: MCC-20832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes