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

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ClinicalTrials.gov Identifier: NCT04879940
Recruitment Status : Not yet recruiting
First Posted : May 10, 2021
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Benign Prostatic Hyperplasia Device: Merit Medical Embospheres Radiation: Radiation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in International Prostate Symptom Score [ Time Frame: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE ]
    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 :
  1. Prostate Volume Reduction after PAE [ Time Frame: At 12 weeks ]
    Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume.

  2. Change in American Urologic Association Score [ Time Frame: At 18 weeks ]
    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".



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04879940


Contacts
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Contact: Yazmin Rodriguez 813-745-3353 Yazmin.Rodriguez@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Contact: Yazmin Rodriguez    813-745-3353    Yazmin.Rodriguez@moffitt.org   
Principal Investigator: Nainesh S Parikh, MD, MBA         
Sub-Investigator: Julio Pow Sang, MD         
Sub-Investigator: Michael Poch, MD         
Sub-Investigator: Brandon Manley, 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         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Nainesh S Parikh, MD, MBA Moffitt Cancer Center
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04879940    
Other Study ID Numbers: MCC-20832
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Prostatic Hyperplasia
Hyperplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site