Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04879940|
Recruitment Status : Not yet recruiting
First Posted : May 10, 2021
Last Update Posted : August 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Carcinoma Benign Prostatic Hyperplasia||Device: Merit Medical Embospheres Radiation: Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|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|
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.
- 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".
- 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.
- 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".
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
|Contact: Yazmin Rodriguez||813-745-3353||Yazmin.Rodriguez@moffitt.org|
|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|
|Principal Investigator:||Nainesh S Parikh, MD, MBA||Moffitt Cancer Center|