Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams

Status unconfirmed · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

Study to evaluate Prostate Artery Embolization for the treatment of lower urinary track symptoms due to Benign Prostatic Hyperplasia and Prostate Size Greater Than 90 Grams.

Key facts

Study ID

NCT02167009

Run by

Tampa General Hospital

People needed

30

Starts

2014-12-01

Expected to finish

2020-05-01

Last updated by the study team

2019-09-10

Who can join

Age: 50 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient is aged 50-85 years
• Patient has signed informed consent
• Patient has experienced lower urinary tract symptoms (LUTS) for at least 1 year prior to study enrollment
• Patient has a prostate size larger than 90g as measured by transrectal ultrasound (TRUS)
• Patient has an IPSS score greater than or equal to 13
• Patient has a peak urine flow rate < 12 mL/sec
• Patient either:
• Refuses surgical treatment
• Is considered high risk for surgical treatment
• Patient is either:
• Refractory to medical treatment
• Contraindicated for medical treatment
• Patient must meet ONE of the following criteria:
• Baseline PSA ≤ 2.5ng/mL
• Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA ≥ 25% of total PSA (no biopsy required)
• Baseline PSA > 2.5 ng/mL and ≤ 10 ng/mL AND free PSA < 25% of total PSA AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months
• Baseline PSA >10 ng/mL AND negative prostate biopsy result (minimum of 12 core biopsy) within 12 months

You may not qualify if…

• History of prostate or bladder cancer, or currently being evaluated for cancer
• History of prostate or bladder cancer, or currently being evaluated for cancer
• Patient has taken alpha blockers within 4 weeks of screening
• Patient has experienced an irregular voiding pattern despite medical management with a stable 5-alpha reductase inhibitor dosage for 3 months or longer
• History of open prostate surgery, radiofrequency, or microwave therapy
• Previous open bladder or rectosigmoid colon surgery
• TURP within the last two years
• Patient has nodularity or induration detected upon digital rectal examination (DRE)
• Neurogenic bladder or other neurological disorder impacting bladder function
• Urethral stricture, bladder neck contracture, other potentially confounding bladder pathology, bladder disease, or confounding urethral pathology
• Acute urinary retention requiring an indwelling catheter
• Bladder atonia
• Active prostatitis or urinary tract infection
• Cystolithiasis within the past 3 months
• Serum creatinine >1.7mg/dL
• Coagulation disturbances not normalized by medical treatment
• Iodinated contrast allergy not controlled with 24-hour steroid preparation
• History of gelatin allergy
• History of pelvic irradiation
• History of severe peripheral vascular disease or known major iliac arterial occlusive disease
• History of smoking greater than 30 pack-years
• Interest in future fertility
• Significant cardiac or respiratory disease that the Investigator believes puts the patient at risk for a complication during the procedure
• Any other risks or factors that the Investigator believes puts the patient at risk for a complication during the procedure

Where it is running

• Tampa General Hospital — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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