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

Benign Prostatic Hyperplasia Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04879940
• Other study ID #: MCC-20832
• Status: Recruiting
• Phase: Phase 2
• Start date: February 23, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Scott Hagen
• Phone: 813-745-0683
• Email: scott.hagen[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Carcinoma
• Hyperplasia
• Prostate Carcinoma
• Prostatic Hyperplasia
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in International Prostate Symptom Score	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".	At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
Secondary	Prostate Volume Reduction after PAE	Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume.	At 12 weeks
Secondary	Change in American Urologic Association Score	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".	At 18 weeks

External Links

•   Moffitt Cancer Center Clinical Trials website