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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032737

Enrollment

232

Registered

2023-10-06

Start date

2023-07-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N40

Interventions

Group 1: Subgroup Particle Embolization Group 2: Subgroup Glue Embolization

Eligibility

Sex/Gender

Male

Age

40 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

France, Germany

Contacts

Public ContactFederico Collettini

Charité - Universitätsmedizin Berlin

federico.collettini@charite.de+4930450657078

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026