Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.

Study Overview

• Status: Terminated
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hypertrophy
• Intervention / Treatment: Device: Embosphere microspheres

Detailed Description

This is a prospective, open labeled, non-randomized, single center feasibility study to evaluate the technical and clinical success of prostatic artery embolization utilizing Embosphere microspheres.

At initial consultation patients will be screened to assess the severity of lower urinary tract symptoms (LUTS) related to BPH utilizing the international prostate symptom score (IPSS). After determining eligibility, pre-procedure baseline evaluation will be completed. A baseline prostate ultrasound (TRUS) or MRI will be required to assess prostate mass, and baseline prostate-specific antigen will be measured to help exclude carcinoma and also to follow response to therapy. Patients with suspected malignancy of the prostate will not be enrolled without a negative biopsy finding. Pre- procedure urodynamic studies will be required to assess additional objective measurements and to exclude other causes of LUTS. Cystoscopy will be performed prior to any intervention to help exclude bladder malignancy.

If the patient qualifies by the level of symptoms (IPSS score ≥12), prostate size ≥ 90 grams and max urinary flow rate (Qmax) ≤ 12, the patient will be asked to consider enrolling in the study. A study investigator will review the proposed treatment and baseline/follow-up schedule. If the patient agrees to participate in the study, baseline data will be collected on a case report form and an appointment will be made for prostate artery embolization in the interventional radiology department.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients selected for this study must meet all of the following criteria:

  • Age ≥ 50 years
  • Lower urinary tract symptoms secondary to BPH as defined by:
  • IPSS Symptom Index ≥ 12
  • Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
  • Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)

Exclusion Criteria:

• Patients meeting any of the following criteria will be excluded from the study.

  • Age less than 50 years
  • Prostate cancer
  • Bladder cancer
  • Severe, life-threatening allergy to iodinated contrast
  • Bilateral internal iliac artery occlusion
  • Causes of obstruction other than BPH such as stricture disease
  • Neurogenic bladder or other causes of bladder atonia
  • Post void residual greater than 250 cc
  • Any contraindication to embolization, including
  • Patients intolerant to occlusion procedures
  • Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
  • Presence or likely onset of vasospasm
  • Presence or likely onset of hemorrhage
  • Presence of severe atheromatous disease
  • Presence of feeding arteries smaller than distal branches from which they emerge
  • Presence of collateral vessel pathways potentially endangering normal territories during embolization
  • History of any illness or surgery that might confound the results of the study, which produces symptoms that might be confused with those of the disease process under consideration, or which poses additional risk to the patient.
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  • Confirmed or suspected bladder cancer
  • Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
  • Previous pelvic irradiation or radical pelvic surgery
  • Recent (within 3 months) cystolithiasis
  • History or presence of urethral strictures, bladder neck contracture, potentially confounding bladder pathology, or (within 5 years) prostatitis
  • Active urinary tract infection

  • Concomitant medications:

    (i) Use of anti histaminics, anti convulsants, and antispasmodics within 1 week of treatment unless there is documented evidence that the patient has been on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) (ii) Use of alpha blockers, anti-cholinergics, androgens, and gonadotropins-releasing hormonal analogs within 2 months of treatment (iii) Use of 5 alpha reductase inhibitors within 6 months of treatment

  • Compromised renal function (i.e. serum creatinine level greater than 1.8 mg/dl, or upper-tract disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embosphere microspheres; Embospheres are calibrated microspheres which will be percutaneously delivered intra-arterially via a microcatheter under fluoroscopic guidance to occlude the prostatic arteries.	Device: Embosphere microspheres; This is a clinical trial assessing the feasibly and safety of prostate artery embolization (PAE) for benign prostatic hypertrophy (BPH) resulting in severe lower urinary tract symptoms (LUTS) in patients with gland size ≥90 grams who are TURP ineligible or non-operative candidates with Embosphere microspheres.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement in Lower Urinary Tract Symptoms (LUTS)	Questionnaire	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	Safety and Tolerability as assess by CTCAE 4.0	12 months
Change in peak urinary flow (Qmax)	Urodynamics	24 months
Change in prostate size	Imaging (MRI or Transrectal ultrasound)	24 months
Change in serum PSA from baseline	Blood test	24 months
Erectile and sexual function questionnaire	Questionnaire	24 months
Pain	Pain Questionnaire	12 months
Post void residual bladder volume (PVR)	Imaging (ultrasound)	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time in minutes	Total PAE time for informational purposes	1 day
Total fluoroscopy time in minutes	Total procedural fluoroscopy time in minutes for informational purposes	1 day
Size of catheter used for embolization	Microcatheter size for informational purposes	1 day
Volume of contrast used in mL	For informational purposes	1 day
Length of hospital stay	Expected to be less than 1 day	1 day
Volume of embolic material used in mL	Total volume per prostatic artery utilized to achieve stasis	1 day
Total fluoroscopy dose mGy	Measured in mGy for informational purposes	1 day

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 17, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms (LUTS); LUTS; BPH; Prostate Artery Embolization; PAE; Prostate Artery Embolization (PAE); Embospheres
• Additional Relevant MeSH Terms: Urological Manifestations; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hypertrophy
• Other Study ID Numbers: 803676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided