RecruitingPhase 2NCT04879940

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

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

26 participants

Start Date

Feb 23, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Carcinoma Benign Prostatic Hyperplasia

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

Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether prostatic artery embolization (PAE) — a minimally invasive procedure that reduces blood flow to the prostate, shrinking it — can help improve urinary symptoms and reduce side effects of radiation therapy in men with low-risk prostate cancer who are choosing radiation as their treatment. **You may be eligible if...** - You have confirmed low-risk or favorable intermediate-risk prostate cancer (Gleason Grade 1 or 2) - Your prostate is between 60 and 150 grams in size - Your urinary symptom score (AUA/IPSS) is 15 or higher, meaning you have moderate-to-severe urinary symptoms - You have chosen radiation therapy for your cancer treatment - You can receive the PAE procedure within 6–12 weeks of your planned radiation **You may NOT be eligible if...** - You have chosen active surveillance instead of radiation - You are currently on androgen deprivation therapy (hormone therapy) - Your cancer is intermediate-unfavorable or high-risk (Gleason Grade 3 or higher) - You have an active urinary tract infection, cystolithiasis, or active prostatitis - You have a severe allergy to the contrast dyes used in the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMerit 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.

RADIATIONRadiation Therapy

Patients will undergo standard of care definitive radiation therapy.