BPH, Enlarged Prostate (BPH), Prostatic Hyperplasia
Conditions
Brief summary
Purpose: The purpose of this study is to determine if prostatic artery embolization (PAE) is as effective as medication (non-inferiority) in reducing urinary symptoms due to benign prostatic hyperplasia (BPH) and to determine if PAE will result in less adverse events compared to medication in individual patients. Participants: Study subjects will be 30 men who have taken BPH medication for at least 6 months and planning to undergo PAE. Subjects will be enrolled across 3 sites. Procedures (methods): This will be a single arm, non-blinded study of PAE using HydroPearl Beads. Subjects will be compared to themselves. The study will involve 6 study visits: an enrollment/baseline visit, the PAE procedure, and 1 day, 3 month, 6 month, and 12 month follow-up visits. Subjects will complete questionnaires and uroflowmetry testing at baseline and each follow-up visit. Subjects will also obtain an MRI at baseline and their 6 month follow-up visit.
Detailed description
This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of 30 subjects with benign prostate hyperplasia (BPH) to investigate the effectiveness of prostatic artery embolization (PAE) relative to previous medication alone for reducing urinary symptoms due to BPH. Secondary aims will be to assess adverse effects of medication vs adverse events secondary to PAE as well as Quality of Life scores on medication vs after PAE.
Interventions
DEVICEProstatic Artery Embolization (HydroPearl® compressible microspheres)
Embolic material
Sponsors
Terumo Medical Corporation
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male * Age ≥ 40 * Prostate gland measures ≥50 grams measured by MRI, CT, or ultrasound * Have previously taken BPH medications including either alpha blockers, 5-alpha reductase inhibitors or the combination of both for 6 months * Capable of giving informed consent * Life expectancy greater than 1 year
Exclusion criteria
* Severe vascular disease as defined by severe arterial calcification seen on prior imaging, history of lower extremity or pelvic bypass grafts or history of lower extremity or pelvic arterial stenting. For patients that do not have prior imaging at UNC, we will rule out suspected severe arterial calcification given their medical history. * Uncontrolled diabetes mellitus which is defined as Hemoglobin A1C \>8% * Patients currently taking SGLT2 inhibitors (cana-, dapa-, empa-, and ertu- gliflozin) due to their diuretic effects * A smoking history of 20 pack-year or greater obtained by patient report * Prior myocardial infarction * A stroke within the last 6 months * Unstable angina * Immunosuppression * Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. * Complete urinary retention * Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis. * Confirmed or suspected bladder cancer as assessed based on patients' medical history or current hematuria * Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology * Ongoing urogenital infection. For patients with symptoms of a urogenital infection (dysuria, fever, etc.), a urinalysis will be obtained. * Previous pelvic radiation or radical pelvic surgery * Confirmed malignancy of the prostate or a history of prostate cancer * Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in IPSS at 6 Months | baseline to 6 months following the procedure | The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Quality of Life Scores at 6 Months | baseline to 6 months following the procedure | The QoL question of the International Prostate Symptom Score (IPSS) is a single question related to the symptoms of the disease benign prostatic hyperplasia (BPH) and ranges from 0 to 6. Lower scores indicate a higher quality of life. |
| Mean Change in Urine Flow | Baseline to 6 months following the procedure | Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s) |
| Incidence of Treatment Related Adverse Events (Percent) | up to 3 months following the procedure | Percent of participants that experience adverse events considered related to the PAE procedure. |
| Mean Percent of Prostate Infarcted | 6 months following the procedure | Individual percentage of prostate infarcted determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast MRI images and data aggregated for the group to report mean percent. |
| Incidence of Treatment Related Adverse Events (Proportion) | up to 3 months following the procedure | Proportion of participants that experience adverse events considered related to the PAE procedure. |
| Mean Change in Prostate Volume | baseline to 6 months following the procedure | Change in the prostate size measured in grams (g). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PAE Procedure This will be a single arm, uncontrolled, non-blinded study of PAE using HydroPearl Beads in a small population of subjects with benign prostate hyperplasia (BPH)
Prostatic Artery Embolization (HydroPearl® compressible microspheres): Embolic material | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | PAE Procedure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 11 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Mean Change in IPSS at 6 Months
The International Prostate Symptom Score (IPSS) includes 7 Likert-type questions related to symptoms with scores ranging from 0 to 5, where 0 is less severe. The IPSS is a written screening tool used to: screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
Time frame: baseline to 6 months following the procedure
Population: Data are reported for all participants with both baseline and Month 6 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAE Procedure | Mean Change in IPSS at 6 Months | -9.64 score on a scale | Standard Deviation 9.04 |
Secondary
Incidence of Treatment Related Adverse Events (Percent)
Percent of participants that experience adverse events considered related to the PAE procedure.
Time frame: up to 3 months following the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAE Procedure | Incidence of Treatment Related Adverse Events (Percent) | 83.3 percentage of participants |
Secondary
Incidence of Treatment Related Adverse Events (Proportion)
Proportion of participants that experience adverse events considered related to the PAE procedure.
Time frame: up to 3 months following the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAE Procedure | Incidence of Treatment Related Adverse Events (Proportion) | 0.83 proportion of participants |
Secondary
Mean Change in Prostate Volume
Change in the prostate size measured in grams (g).
Time frame: baseline to 6 months following the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAE Procedure | Mean Change in Prostate Volume | -21.10 grams | Standard Deviation 24.63 |
Secondary
Mean Change in Quality of Life Scores at 6 Months
The QoL question of the International Prostate Symptom Score (IPSS) is a single question related to the symptoms of the disease benign prostatic hyperplasia (BPH) and ranges from 0 to 6. Lower scores indicate a higher quality of life.
Time frame: baseline to 6 months following the procedure
Population: Data are reported for all participants with both baseline and Month 6 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAE Procedure | Mean Change in Quality of Life Scores at 6 Months | -2.00 score on a scale | Standard Deviation 1.41 |
Secondary
Mean Change in Urine Flow
Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second (mL/s)
Time frame: Baseline to 6 months following the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAE Procedure | Mean Change in Urine Flow | 0.26 mL/s | Standard Deviation 5.25 |
Secondary
Mean Percent of Prostate Infarcted
Individual percentage of prostate infarcted determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast MRI images and data aggregated for the group to report mean percent.
Time frame: 6 months following the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAE Procedure | Mean Percent of Prostate Infarcted | 23 percent entire prostate volume infarcted | Standard Deviation 9.19 |