Clinical Trials /

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

NCT04879940

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: MCC-20832
  • NCT ID: NCT04879940

Conditions

  • Prostate Carcinoma
  • Benign Prostatic Hyperplasia

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Prostatic Artery Embolization (PAE)ExperimentalParticipants who receive PAE with Merit Medical Embospheres.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically or cytologically confirmed prostate adenocarcinoma in the very low or
                 low risk risk stratification groups (i.e. Grade group 1 or Gleason score ≤ 6) and
                 eligible for radiation therapy.
    
              -  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:
    
              -  Receiving androgen deprivation therapy (ADT)
    
              -  Patients with intermediate 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 150 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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Change in International Prostate Symptom Score
    Time Frame:At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
    Safety Issue:
    Description: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".

    Secondary Outcome Measures

    Measure:Prostate Volume Reduction after PAE
    Time Frame:At 12 weeks
    Safety Issue:
    Description:Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume.
    Measure:Change in American Urologic Association Score
    Time Frame:At 18 weeks
    Safety Issue:
    Description: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".

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

    Last Updated

    May 11, 2021