PROstate artery embolization using TRis-acryl Gelatin microspheres or n-ButylcyAnoaCrylaTe (PROTRACT): a multicenter randomized clinical trial

Not Applicable

Recruiting

Conditions: N40
Hyperplasia of prostate

Registration Number: DRKS00032737

Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 232

Inclusion Criteria

1.Men > 40 years of age
2.Patients referred to interventional radiology for PAE.
3.Written informed consent
4.Ability to meet the requirements of the study procedures.

Exclusion Criteria

1.Prior surgical BPH therapy
2.Suspicion of clinically significant prostate cancer
3.Subject is ineligible for pelvic angiography
4.History of urethral stricture or its treatment
5.Known or suspected neurogenic bladder dysfunction
6.Contraindication to intravascular iodinated contrast, e.g., allergies or severely elevated creatinine/renal failure
7.Uncorrected coagulopathy
8.Allergy to one of the intended embolics
9.Mental status precluding performance of the study or obtaining informed consent

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) - Absolute and relative changes in IPSS score [time frames: baseline, 3, 6, 12, 18, and 24 months]

Secondary Outcome Measures

Name	Time	Method
a.Number of adverse events (AE).<br>b.Radiation exposure to patients and staff (dose-area product [DAP], in Gy cm(2) and fluoroscopy time [FT] in minutes).<br>c.Degree of reduction in prostate size, perfusion and stiffness assessed by MRI [time frame: baseline, 12 and 24 months].<br>d.Change in residual urine volume after voiding (PVR) [time frames: baseline, 3, 6, 12, and 24 months].<br>e.Change in prostate specific antigen (PSA) [time frame: baseline, 12, and 24 months].<br>f.International Index of Erectile Function (IIEF-5) absolute and relative changes in IIEF-5 score [time frames: baseline, 3, 6, 12, 18, and 24 months].<br>g.Change in need for prostate-specific medications [time frame: baseline, 3, 6, 12, 18, and 24 months].<br>h.Change in ejaculation antegrade vs. retrograde [time frame: baseline, 3, 6, 12, 18, and 24 months].