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

NCT ID: NCT04879940

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Prostatic Artery Embolization (PAE)

Participants who receive PAE with Merit Medical Embospheres.

Group Type: EXPERIMENTAL

Merit Medical Embospheres

Intervention Type: 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.

Radiation Therapy

Intervention Type: RADIATION

Patients will undergo standard of care definitive radiation therapy.

Interventions

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.

Intervention Type: DEVICE

Radiation Therapy

Patients will undergo standard of care definitive radiation therapy.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nainesh S Parikh, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine Darbouze

Role: CONTACT

Christine.Darbouze@moffitt.org

813-745-8919

Related Links

https://www.moffitt.org/clinical-trials-research/clinical-trials/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

MCC-20832

Identifier Type: -

Identifier Source: org_study_id