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Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT01789840
Recruitment Status : Terminated (510(K) Approval Gained for Product)
First Posted : February 12, 2013
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Tracking Information
First Submitted Date  ICMJE February 8, 2013
First Posted Date  ICMJE February 12, 2013
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
IPSS Score [ Time Frame: 12 months ]
The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • Duration of hospitalization post procedure [ Time Frame: 1 month ]
    The duration of hospitalization associated with the procedure will be calculated in hours.The difference in treatment means will be calculated, including the corresponding 95% confidence interval, and treatment groups will be compared using Student's t-test for the ITT and Evaluable populations. If the distribution of the data is found to differ substantially from normal, appropriate methods will be used to analyze the data, including a data transformation or time to event analysis.
  • Duration of post procedure catheterization [ Time Frame: 1 month ]
    The duration of post procedure catheterization will be calculated in hours. The difference in treatment means will be calculated, including the corresponding 95% confidence interval and treatment groups will be compared using Student's t-test for the ITT and Evaluable populations. If the distribution of the data is found to differ substantially from normal, appropriate methods will be used to analyze the data, including a data transformation or time to event analysis.
  • Overall adverse events [ Time Frame: 12 months ]
    Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the CRF which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.
  • Procedure related adverse events [ Time Frame: 12 months ]
    Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the CRF which began prior to treatment will not be included in the summary tables but will be included in the AE data listings.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
  • Duration of hospitalization post procedure [ Time Frame: 1 month ]
  • Duration of post procedure catheterization [ Time Frame: 1 month ]
  • Overall and procedure related adverse events [ Time Frame: 12 months ]
  • Safety [ Time Frame: 12 months ]
    Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and finding on physical examination.
Current Other Pre-specified Outcome Measures
 (submitted: August 31, 2020)
  • Change from baseline in peak urine flow rate (Qmax) [ Time Frame: 12 months ]
    The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments will be summarized for both treatment groups for the baseline and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.
  • Change from baseline in erectile function using the International Index of Erectile Function (IIEF) [ Time Frame: 12 months ]
    Each subscale will be summarized separately for both treatment groups for the baseline, 1 month, 3 month, 6 month, and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.
    • Erectile Function (items 1, 2, 3, 4, 5, 15)
    • Orgasmic Function (items 9, 10)
    • Sexual Desire (items 11, 12)
    • Intercourse Satisfaction (items 6, 7, 8)
    • Overall Satisfaction (items 13, 14)
  • Change from baseline in mean prostate volume, as determine by MRI [ Time Frame: 12 months ]
    The mean prostate volume as assessed by MRI will be summarized for both treatment groups for the baseline, 3 month and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.
  • Change from baseline in post-void residual urinary volume (PVR) [ Time Frame: 12 months ]
    The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments will be summarized for both treatment groups for the baseline and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.
  • Change in baseline from prostate specific antigen (PSA) [ Time Frame: 12 months ]
    Prostate specific antigen (PSA) will be summarized for both treatment groups for the baseline, 1 month, 3 month, 6 month, and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.
Original Other Pre-specified Outcome Measures
 (submitted: February 11, 2013)
  • Change from baseline in peak urine flow rate (Qmax) [ Time Frame: 12 months ]
  • Change from baseline in erectile function using the International Index of Erectile Function (IIEF) [ Time Frame: 12 months ]
  • Change from baseline in mean prostate volume, as determine by MRI [ Time Frame: 12 months ]
  • Change from baseline in post-void residual urinary volume (PVR) [ Time Frame: 12 months ]
  • Change from baseline in detrusor muscle pressure (Pdet) [ Time Frame: 12 months ]
  • Change in baseline from prostate specific antigen (PSA) [ Time Frame: 12 months ]
 
Descriptive Information
Brief Title  ICMJE Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia
Official Title  ICMJE Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia
Brief Summary The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Device: Embosphere Microspheres
  • Procedure: TURP
    Other Name: TURP - Transurethal resection of the prostate
Study Arms  ICMJE
  • Experimental: Prostate artery emoblization (PAE)
    Prostate artery embolization using Embosphere Microspheres
    Intervention: Device: Embosphere Microspheres
  • Active Comparator: Transurethral resection of the prostate (TURP)
    Transurethral Resection of the Prostate (TURP)
    Intervention: Procedure: TURP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2017)
59
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2013)
186
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is age 50 to 79, inclusive
  2. Patient has signed informed consent
  3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
  4. Patient has a baseline IPSS Score > 13 at baseline
  5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
  6. Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused
  7. Patient must be a candidate for TURP
  8. Patient must meet ONE of the following criteria:

    • Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required)
    • Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA > 25% of total PSA (no prostate biopsy required)
    • Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA < 25% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
    • Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

Exclusion Criteria:

  1. Active urinary tract infection
  2. Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer

    • The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:

      • Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
      • Patients with baseline PSA levels > 10 ng/mL
      • Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA < 25% of total PSA
    • Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
  3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
  4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
  5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern

    • Dosage of these medications should not change during study participation unless medically necessary

  6. Patient has taken antidepressants, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
  7. Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
  8. Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
  9. Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
  10. Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug (NSAID) or anti-platelet therapy for 7 days prior to study treatment
  11. Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint, etc)
  12. Patient has an asymmetric prostate, with > 20% difference in size between lobes
  13. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months
  14. Baseline serum creatinine level > 1.8 mg/dl
  15. Known upper tract renal disease
  16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment
  17. Active prostatitis
  18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
  19. History of pelvic irradiation or radical pelvic surgery
  20. Patient is interested in future fertility
  21. Coagulation disturbances not normalized by medical treatment
  22. Acute urinary retention requiring an indwelling catheter
  23. Known major iliac arterial occlusive disease
  24. Allergy to iodinated contrast agents
  25. Hypersensitivity to gelatin products
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Belgium,   Brazil,   France
 
Administrative Information
NCT Number  ICMJE NCT01789840
Other Study ID Numbers  ICMJE BPH-P3-12-01
2012-003446-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merit Medical Systems, Inc.
Study Sponsor  ICMJE Merit Medical Systems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco Cesar Carnevale, PhD University of Sao Paolo, Brazil
PRS Account Merit Medical Systems, Inc.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP