BPH
Conditions
Keywords
embolization, prostate
Brief summary
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization. Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study. Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
Detailed description
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
Interventions
LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.
Sponsors
BTG International Inc.
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male 2. Age \> 40 3. Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA) 4. Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects 5. Moderate to severe LUTS as defined by IPSS score \>18 6. Peak urine flow rate (Qmax) \<12 mL/sec 7. Capable of giving informed consent 8. Life expectancy greater than 1 year
Exclusion criteria
1. Severe vascular disease 2. Uncontrolled diabetes mellitus 3. Immunosuppression 4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. 5. Complete urinary retention 6. 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. 7. Confirmed or suspected bladder cancer 8. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology 9. Ongoing urogenital infection 10. Previous pelvic radiation or radical pelvic surgery 11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy). 12. Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000 13. Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in IPSS Score | Baseline and 6 months following PAE procedure | The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. 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 Urine Flow | Baseline and 6 months following PAE Procedure | Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second. |
| Mean Change in Prostate Volume | Baseline and 3 months following | Change in the prostate volume measured in grams. |
| Percent of Prostate Infarcted | 6 months following PAE procedure | Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume. |
| Mean Change in Quality of Life Scores | Baseline and 6 months following PAE procedure | The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5. |
| Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure | Up to 12 months following PAE procedure | Number of participants that experience minor complications following the PAE procedure. |
| Mean Change in IIEF Score | Baseline and 6 months following PAE procedure | Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function. |
| Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure | 3 months following PAE procedure | Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Patients will receive the Prostatic Artery Embolization procedure.
Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Closed | 8 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| IIEF | 46 units on a scale STANDARD_DEVIATION 22 |
| IPSS | 22.5 units on a scale STANDARD_DEVIATION 4.2 |
| Quality of Life | 4.5 units on a scale STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 14 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
| Urine Flow (mL/s) | 7.9 mL/s STANDARD_DEVIATION 4.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Mean Change in IPSS Score
The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. 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 and 6 months following PAE procedure
Population: This group includes all subjects that received the PAE procedure with 6 month follow up IPSS data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With 6 Month Follow up | Mean Change in IPSS Score | -11.4 units on a scale | Standard Deviation 8.4 |
Secondary
Mean Change in IIEF Score
Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function.
Time frame: Baseline and 6 months following PAE procedure
Population: All patients that received the PAE procedure and had 6 month follow up data for IIEF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With 6 Month Follow up | Mean Change in IIEF Score | -1.1 units on a scale | Standard Deviation 13.4 |
Secondary
Mean Change in Prostate Volume
Change in the prostate volume measured in grams.
Time frame: Baseline and 3 months following
Population: All participants receiving the PAE procedure with imaging following the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With 6 Month Follow up | Mean Change in Prostate Volume | -20 grams | Standard Deviation 23.2 |
Secondary
Mean Change in Quality of Life Scores
The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5.
Time frame: Baseline and 6 months following PAE procedure
Population: This group includes all patients that received the PAE procedure and had 6 month QoL data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With 6 Month Follow up | Mean Change in Quality of Life Scores | -2 units on a scale | Standard Deviation 1.3 |
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.
Time frame: Baseline and 6 months following PAE Procedure
Population: Patients with 6-month urodynamic testing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With 6 Month Follow up | Mean Change in Urine Flow | 3.3 mL/s | Standard Deviation 4.5 |
Secondary
Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure
Number of participants that experience minor complications following the PAE procedure.
Time frame: Up to 12 months following PAE procedure
Population: All patients that received the PAE procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With 6 Month Follow up | Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure | 8 Participants |
Secondary
Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure
Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation.
Time frame: 3 months following PAE procedure
Population: All patients that received the PAE procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With 6 Month Follow up | Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure | 8 Participants |
Secondary
Percent of Prostate Infarcted
Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume.
Time frame: 6 months following PAE procedure
Population: Unable to collect infarction data because the CT scans did not show it effectively.