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Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

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ClinicalTrials.gov Identifier: NCT02676544
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Albert Scappaticci, Rhode Island Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hypertrophy Lower Urinary Tract Symptoms Device: Embosphere microspheres Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Clinical Improvement in Lower Urinary Tract Symptoms (LUTS) [ Time Frame: 24 months ]
    Questionnaire


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 12 months ]
    Safety and Tolerability as assess by CTCAE 4.0

  2. Change in peak urinary flow (Qmax) [ Time Frame: 24 months ]
    Urodynamics

  3. Change in prostate size [ Time Frame: 24 months ]
    Imaging (MRI or Transrectal ultrasound)

  4. Change in serum PSA from baseline [ Time Frame: 24 months ]
    Blood test

  5. Erectile and sexual function questionnaire [ Time Frame: 24 months ]
    Questionnaire

  6. Pain [ Time Frame: 12 months ]
    Pain Questionnaire

  7. Post void residual bladder volume (PVR) [ Time Frame: 24 months ]
    Imaging (ultrasound)


Other Outcome Measures:
  1. Procedural time in minutes [ Time Frame: 1 day ]
    Total PAE time for informational purposes

  2. Total fluoroscopy time in minutes [ Time Frame: 1 day ]
    Total procedural fluoroscopy time in minutes for informational purposes

  3. Size of catheter used for embolization [ Time Frame: 1 day ]
    Microcatheter size for informational purposes

  4. Volume of contrast used in mL [ Time Frame: 1 day ]
    For informational purposes

  5. Length of hospital stay [ Time Frame: 1 day ]
    Expected to be less than 1 day

  6. Volume of embolic material used in mL [ Time Frame: 1 day ]
    Total volume per prostatic artery utilized to achieve stasis

  7. Total fluoroscopy dose mGy [ Time Frame: 1 day ]
    Measured in mGy for informational purposes



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676544


Contacts
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Contact: Susan M Foley, RTRCV, CCRP 401-444-2980 smfoley@lifespan.org
Contact: Wendy J Smith, BS, RTRCV, CCRP 401-444-4233 wsmith@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Susan M Foley, RTRCV, CCRP    401-444-2980    smfoley@lifespan.org   
Contact: Wendy J Smith, BS, RTRCV, CCRP    401-444-4233    wsmith@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital

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Responsible Party: Albert Scappaticci, PhD, MD, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02676544     History of Changes
Other Study ID Numbers: 803676
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Albert Scappaticci, Rhode Island Hospital:
Prostate Artery Embolization (PAE)
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)
PAE
BPH
LUTS
Prostate Artery Embolization
Embospheres

Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hypertrophy
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male