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ACTIVE NOT RECRUITING
NCT04879940
PHASE2

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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

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

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2022-02-23

Completion Date

2026-08

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

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 (1)

Moffitt Cancer Center

Tampa, Florida, United States