This phase 1/2 trial aims to evaluate the safety of prostate artery embolization in treating urinary symptoms due to benign prostatic hyperplasia (BPH). The main outcome to be investigated is the occurrence of side effects. The trial is recruiting in Minneapolis (Minnesota), USA.
The details
BPH can lead to bothersome urinary symptoms that often require surgery targeting the enlarged prostate tissue. Prostate artery embolization (PAE) has been developed as a minimally invasive alternative to reduce prostate size without actually removing prostate tissue. During PAE, a small catheter is placed in the groin. Particles are injected into the local arteries, which decreases blood supply to the prostate, and therefore reduce prostate size.
This study will examine the safety of PAE. The occurrence of side effects will be recorded over a period of 3 months. Changes in urinary symptoms and quality of life will also be recorded using questionnaires and a measure of urine flow rate.
Who are they looking for?
This study will recruit about 100 men aged 45 years or older, who continue to have moderate-to-severe urinary symptoms due to BPH despite medical treatment for at least 6 months. Men should have a prostate size of at least 40 grams. PSA (prostate specific antigen; a protein elevated in the blood in prostate cancer) levels, a prostate biopsy, or rectal examination should test negative for prostate cancer.
The current use of medication for urinary symptoms (including alpha-blockers, 5-alpha reductase inhibitors, anticholinergic medication, hormones, and steroids) will be assessed and may need to be stopped for at least 2 weeks before taking part unless on a stable dose of medication. Patients cannot take part in the trial if they have a history of prostate or bladder cancer, pelvic radiation, prostate surgery, kidney/bladder stones, or bleeding disorder. Urinary symptoms due to a neurological condition such as Parkinson’s disease will prevent patients from taking part. Participants should not have a history of chronic prostate inflammation within the past year. Participants should not have any past or current heart disease, uncontrolled diabetes, respiratory disorder, immune disorder, poor kidney function, an active urinary tract infection, or any any significant or uncontrolled medical illnesses.
How will it work
All participants will undergo PAE. After the procedure, patients will be followed for 3 months to assess the occurrence of side effects. Changes in urinary symptoms and quality of life will also be recorded using questionnaires and a measure of urine flow rate.
