Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia

NCT02074644 | Completed

• 1 other identifier: PAE-01-2013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether prostatic arterial embolization (PAE) compared is an effective and safe treatment for benign prostatic hyperplasia in patients with severe lower urinary tract symptoms not adequately controlled by medical therapy with alpha-blockers, as assessed by the the International Prostate Symptom Score (IPSS) after 6 months. Patients will be randomized on a 1:1 ratio to PAE or to a sham procedure and evaluated at 1, 3 and 6 months. Patients randomized to the sham procedure will be offered the possibility of performing PAE after 6 months. All patients may participate on an optional 6-months extension study.

Conditions

Prostatic Hyperplasia, Benign; Prostatic Hypertrophy, Benign; Genital Diseases, Male; Lower Urinary Tract Symptoms; Prostatic Diseases

Keywords

Prostatism; Randomized Controlled Trial; Embolization, Therapeutic; Hyperplasia; Prostatic Diseases; Genital Diseases, Male

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the International Prostate Symptom Score

  The difference between the baseline value and the value observed at the last valid observation of a validated questionnaire that measures the disconfort caused by lowere urinary tract symptoms

  6 months

Secondary Outcomes (1)

• Disease specific quality of life question of the International Prostate Symptom Score

  6 months

Other Outcomes (6)

• Change from baseline in the Benign Prostatic Hyperplasia Impact Index (BPH-II)

  6 months

• Change from baseline in the International Index of Erectile Function (IIEF)

  6 months

• Change from baseline in the peak urinary flow rate (Qmax)

  6 months

Study Arms (2)

Prostatic Arterial Embolization

EXPERIMENTAL

Selective catheterization of the prostatic arteries followed by slow injection of Bead Block 300-500 or PVA 100+200 micra particles under fluoroscopic control.

Procedure: Prostatic Arterial Embolization

Sham procedure

SHAM COMPARATOR

Selective catheterization of the prostatic arteries followed by removal of the catheter with no particles injected.

Procedure: Sham procedure

Interventions

Prostatic Arterial Embolization PROCEDURE

The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. Bead Block 300-500 or PVA 100+200 micra particles are slowly injected under fluoroscopic control until the end point is reached. Embolization is considered finished when there is "near stasis" in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification checked in both oblique and AP views. Upon finishing the embolization of the left prostatic arteries, the right prostatic arteries are embolized in the same way.

Prostatic Arterial Embolization

Sham procedure PROCEDURE

The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. The catheter is removed and no particles are injected.

Sham procedure

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients ≥ 45 years-old
• Diagnosis of BPH based on clinical history, digital rectal examination, urine sediment, transrectal prostate ultrasound and PSA
• Use of a marketed alpha-blocker for LUTS/BPH in the previous 6 months
• Severe lower urinary tract symptoms at screening and baseline defined by all the following: IPSS (7 items) ≥ 20, QoL ≥ 3, Qmax \< 12 mL/s and prostate volume ≥ 40 mL
• CTA shows that prostatic arteries are feasible for PAE
• Sexual dysfunction or accepting the risk of developing sexual dysfunction after treatment
• Written informed consent

You may not qualify if:

• Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment
• Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months
• History of prostate or bladder cancer or pelvic irradiation
• Active or recurrent urinary tract infections (more than 1 episode in the last 12 months)
• History of neurogenic bladder or LUTS secondary to neurological disease
• Advanced atherosclerosis and tortuosity of iliac and prostatic arteries
• Secondary renal insufficiency (due to prostatic obstruction)
• Large bladder diverticula or stones
• Detrusor failure
• Previous history of acute urinary retention
• Current severe, significant or uncontrolled disease (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥95 mmHg), congestive heart failure \[New York Heart Association status of class III or IV\], myocardial infarction within 26 weeks prior to randomization), which in the judgment of the clinical investigator renders the subject unsuitable for the trial and puts the subject at increased risk
• Any bleeding disorder such as hemophilia, clotting factor deficiency, anti-coagulation or bleeding diathesis
• Hypersensitivity or contraindication to tamsulosin use
• Administration of 5-ARIs, finasteride and dutasteride in the previous 2 weeks and 4 months, respectively. These patients may be included if they stop those medications and replace them for tansulosin, alfuzosin or silodosin for at least 2 weeks and 4 months, respectively.
• Any mental condition or disorder that would interfere with the subject's ability to provide informed consent

Sponsors & Collaborators

• João Martins Pisco: lead

Study Sites (1)

Hospital de Saint Louis

Lisbon, 1200-249 Lisboa, Portugal

Location

Related Publications (1)

• Pisco JM, Bilhim T, Costa NV, Torres D, Pisco J, Pinheiro LC, Oliveira AG. Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia. Eur Urol. 2020 Mar;77(3):354-362. doi: 10.1016/j.eururo.2019.11.010. Epub 2019 Dec 10.

  PMID: 31831295 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Genital Diseases, Male; Lower Urinary Tract Symptoms; Prostatic Diseases; Prostatism; Hyperplasia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• João M Pisco, M.D,. Ph.D.

  Hospital de Saint Louis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: September 2, 2014
• Primary Completion: March 3, 2019
• Study Completion: March 3, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From January 2020
• Access Criteria: Deidentified participant data and data dictionary will be made available upon request to oliveira.amg@gmail.com with the submission of a study protocol and subsequent approval by the Research Ethics Committee of the institution where the trial was conducted.

Locations

PT (1)