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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Hospital St. Louis, Lisbon, Portugal
Sponsor:
Information provided by (Responsible Party):
João Martins Pisco, Hospital St. Louis, Lisbon, Portugal
ClinicalTrials.gov Identifier:
NCT02074644
First received: February 26, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Prostatic Hyperplasia, Benign
Prostatic Hypertrophy, Benign
Genital Diseases, Male
Lower Urinary Tract Symptoms
Prostatic Diseases
Procedure: Prostatic Arterial Embolization
Procedure: Sham procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized, Evaluator-blind, Controlled Trial to Evaluate the Efficacy and Safety of Prostatic Arterial Embolization Versus a Sham Procedure for Benign Prostatic Hyperplasia With Severe LUTS Not Adequately Controlled With Alpha-blockers

Resource links provided by NLM:


Further study details as provided by Hospital St. Louis, Lisbon, Portugal:

Primary Outcome Measures:
  • Change from baseline in the International Prostate Symptom Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease specific quality of life question of the International Prostate Symptom Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline in the Benign Prostatic Hyperplasia Impact Index (BPH-II) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in the International Index of Erectile Function (IIEF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change from baseline in the peak urinary flow rate (Qmax) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in the post-void residual volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in prostate volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in the Prostate Specific Antigen (PSA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostatic Arterial Embolization
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.
Procedure: Prostatic Arterial Embolization
Sham Comparator: Sham 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 cathether is removed and no particles are injected.
Procedure: Sham procedure

Detailed Description:

This is a randomized, parallel-group, evaluator-blind, superiority, controlled clinical trial of PAE versus a sham procedure in patients with BPH with severe LUTS not adequately controlled by medical therapy with alpha-blockers.

This study has a screening visit at day -14, a baseline visit at day -2, a randomization and intervention visit at day 0, follow up visits at months 1, 3 and 6.

Patients initially randomized to the sham procedure and who completed the 6 month follow-up period will be offered the possibility of performing PAE at no cost. All patients will be invited to participate in a 6 months post-trial extension study.

Patients over 45 years-old with a diagnosis of BPH associated with severe LUTS defined by an IPSS>=20 after a minimum of 6 months treatment with alpha-blockers and with a prostate volume ≥ 40 mL will start a two weeks screening period. Eligible patients will be started on tamsulosin 0.4 mg q.d. and have the intervention scheduled for the following 2 days (study day 0), when they will be randomized to PAE or to a sham procedure if the procedure is technically feasible

Those patients in whom angiography has shown that PAE is technically feasible will be randomized to one of the study arms on a 1:1 ratio. Patients in both groups will be submitted to exactly the same procedure, except that patients randomized to the control group will not be injected with polyvinyl alcohol particles. Patients will be discharged as soon as their clinical condition is stabilized

Patients will be assessed at 1, 3 and 6 months with IPSS, QoL, IIEF, BPH-II and will perform prostatic ultrasonography, uroflowmetry and PSA at month 1 and 6. At 1 month a pelvic NMR will be performed to evaluate prostate volume and the degree of ischemia.

Patients completing the 6 month follow-up period will be invited to enter a 6 months extension study. In this extension study, patients will be evaluated at month 12 for all efficacy variables. Patients initially randomized to the sham procedure who wanted to perform PAE after the conclusion of the trial will be evaluated only at months 1, 3 and 6 after PAE.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Successful catheterization of one of the prostatic arteries
  • Sexual dysfunction or accepting the risk of developing sexual dysfunction after treatment
  • Written informed consent

Exclusion Criteria:

  • 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 6 and 3 months, respectively
  • Any mental condition or disorder that would interfere with the subject's ability to provide informed consent
  • Participation in a study of any investigational drug or device in the previous 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074644

Contacts
Contact: João M Pisco, M.D., Ph.D +(351)968069178 joaopisco1@hotmail.com

Locations
Portugal
Hospital de Saint Louis Not yet recruiting
Lisboa, Portugal, 1200-249 Lisboa
Contact: João M Pisco, M.D., Ph.D.    +(351)968069178      
Principal Investigator: João M Pisco, M.D., Ph.D.         
Sponsors and Collaborators
João Martins Pisco
Investigators
Study Director: João M Pisco, M.D,. Ph.D. Hospital de Saint Louis
  More Information

Publications:
Responsible Party: João Martins Pisco, Professor, Hospital St. Louis, Lisbon, Portugal
ClinicalTrials.gov Identifier: NCT02074644     History of Changes
Other Study ID Numbers: PAE-01-2013
Study First Received: February 26, 2014
Last Updated: April 1, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Hospital St. Louis, Lisbon, Portugal:
Prostatism
Randomized Controlled Trial
Embolization, Therapeutic
Hyperplasia
Prostatic Diseases
Genital Diseases, Male

Additional relevant MeSH terms:
Prostatic Hyperplasia
Genital Diseases, Male
Hyperplasia
Hypertrophy
Prostatic Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014