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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Merit Medical Systems, Inc.
- Enrollment
- 59
- Locations
- 10
- Primary Endpoint
- International Prostate Symptom Score (IPSS) - Total Score at 12 Months
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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
The study will consist of a screening period in which patient eligibility will be determined and baseline assessments performed. Once eligibility is confirmed, patients will be enrolled within 4 weeks of baseline imaging to receive either TURP or PAE with Embosphere Microspheres. After treatment, patients will return for follow-up visits at Months 1, 3, 6, and 12. At each of these visits patients will complete IPSS and IIEF questionnaires and have a physical exam, laboratory assessments (including PSA), a DRE, and a transrectal ultrasound of the prostate. At each visit patients will have a cystoscopy and proctoscopy if medically indicated. Cystoscopy is necessary in all cases of hematuria (injury associated with bleeding). Proctoscopy is necessary in all cases of bleeding per the rectum. An MRI of the prostate will be conducted at the 3 and 12 month visits. Uroflowmetry testing will be performed at the 1 and 12 month visits, and at other visits if medically indicated. MRIs will be assessed by blinded Central Reviewers. The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post treatment. Patients will continue to be followed annually for up to 4 additional years. At a minimum, patients will be requested to complete the IPSS and International Index of Erectile Dysfunction (IIEF) questionnaires by telephone, email or mail once per year during this long term follow up period. Patients who are willing to return to the clinic will have a physical exam, MRI of the prostate, digital rectal exam (DRE), transrectal ultrasound of the prostate, PSA, and uroflowmetry testing performed each year. Treatments for LUTS due to BPH after the study treatment and 12 month follow up are complete will be documented during the long term follow up period to the extent possible. This long term follow up data will be summarized and submitted separately from the data for the initial 12 months of this study. Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and findings on physical examination. Concomitant medication usage will be assessed. A follow up ECG will be performed at the 12 month visit. Patient recruitment is anticipated to take approximately 2 years. Duration of each patient's participation is expected to be 5 years, including a 4 year long term follow up period. The total duration of the study will be approximately 7 years, including long term follow up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is age 50 to 79, inclusive
- •Patient has signed informed consent
- •Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
- •Patient has a baseline IPSS Score \> 13 at baseline
- •Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
- •Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused
- •Patient must be a candidate for TURP
- •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)
Exclusion Criteria
- •Active urinary tract infection
- •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
- •Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- •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
- •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
Outcomes
Primary Outcomes
International Prostate Symptom Score (IPSS) - Total Score at 12 Months
Time Frame: 12 months
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months.
Secondary Outcomes
- Duration of Hospitalization Post Procedure(1 month)
- Duration of Post Procedure Catheterization(1 month)
- Number of Adverse Events Per Patient(Through early termination of study (with less than 25% of subjects completing 12 month follow up))
- Number of Patients With Procedure Related Adverse Events(TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up)