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

NCT04879940 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: MCC-20832
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Carcinoma; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prostate Volume Reduction after PAE

  At 12 weeks

• Change in American Urologic Association Score

  At 18 weeks

Study Arms (1)

Prostatic Artery Embolization (PAE)

EXPERIMENTAL

Participants who receive PAE with Merit Medical Embospheres.

Device: Merit Medical Embospheres; Radiation: Radiation Therapy

Interventions

Merit Medical Embospheres DEVICE

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.

Prostatic Artery Embolization (PAE)

Radiation Therapy RADIATION

Patients will undergo standard of care definitive radiation therapy.

Prostatic Artery Embolization (PAE)

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nainesh S Parikh, MD, MBA

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: February 23, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)