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

Clinicaltrials.gov ID: NCT04879940
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 50 Years
b-bullseye-arrow Enrollments 26

Conditions

Prostate Carcinoma, Benign Prostatic Hyperplasia

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

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Nainesh S Parikh, MD, MBA

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.

Study Plan

Prostatic Artery Embolization (PAE)

EXPERIMENTAL

Participants who receive PAE with Merit Medical Embospheres.

  • DEVICE:

    Merit Medical Embospheres

    Description:

    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

    Description:

    Patients will undergo standard of care definitive radiation therapy.

Outcome Measures

Primary Outcome Measures

Change in International Prostate Symptom Score

Time Frame: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE

Secondary Outcome Measures

Prostate Volume Reduction after PAE

Time Frame: At 12 weeks

Change in American Urologic Association Score

Time Frame: At 18 weeks

Timeline

  • Last Updated
    January 9, 2025
  • Start Date
    May 10, 2021
  • Today
    May 11, 2025
  • Completion Date ( Estimated )
    February 1, 2025

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