Enlarged Prostate With Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Benign
Conditions
Keywords
prostate artery embolization (PAE), benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS)
Brief summary
Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia
Detailed description
This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post PAE.
Interventions
DEVICEEmbosphere microparticles for prostate artery embolization
Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Prostate volume between 40 and 300 cm3 2. Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following: * a. IPSS greater than 18 * b. IPSS Quality of Life (QoL) assessment greater than 3 * c. Qmax less than 12 mL/sec 3. Refractory or intolerant to medical management 4. Ineligibility for or refusal of surgical management 5. One of the following criteria: * a. Baseline prostate specific antigen (PSA) ≤2.5 ng/mL * b. Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA ≥25% of total PSA * c. Baseline PSA \>2.5 ng/mL and ≤10 ng/mL AND free PSA \<25% of total PSA AND negative 12 core prostate biopsy in the past 12 months * d. Baseline PSA \>10 ng/mL AND negative 12 core biopsy within the past 12 months.
Exclusion criteria
1. History of prostate, bladder or rectal malignancy. Biopsy proven urethral cancer. 2. History of rectal disease 3. Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing. 4. Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than BPH, as demonstrated on urodynamic testing 5. Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm 6. Cystolithiasis within the past three months 7. Baseline serum creatinine greater than 1.8 8. Evidence of tortuous or atherosclerotic blood vessels 9. Presence of collateral vessel pathways potentially endangering normal territories during embolization that cannot be bypassed with the microcatheter 10. Active urinary tract infection, interstitial cystitis, or prostatitis within the last 5 years 11. Coagulation disturbances not normalized by medical treatment 12. Allergy to iodinated contrast agents not responsive to steroid premedication regimen 13. Previous radical pelvic or rectal surgery, or pelvic irradiation 14. Prior surgical prostate intervention 15. Treatment with beta-blocker, antihistamine, anticonvulsant, or antispasmodic medication within 1 week of treatment UNLESS there has been a stable voiding pattern while medicated with the drug(s) for 6 months 16. Use of prostate active medications, including alpha blockers, anti-cholinergics, androgens, anti-androgens, gonadotropins-releasing hormonal analogs, PDE5-inhibitors, 5-alpha reductase inhibitors within 2 months of intervention, unless the medication is necessary to avoid symptom exacerbation and disability, in this case medication should not be initiated or dose adjusted within 1 month of study enrollment and dose should not be adjusted during the study period 17. Interest in future fertility 18. Mental condition or disorder that interferes with participants' ability to provide written informed consent 19. Current severe or uncontrolled disease (metabolic, hematologic, renal, hepatic, pulmonary, neurologic, cardiac, infectious or gastrointestinal) that in the Investigator's judgment makes the patient unsuitable for trial inclusion due to increased risk of complications 20. Known immunosuppression 21. Life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 12 months | The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | baseline, 1 month, 6 month | International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms. |
| Change in Post-void Residual (PVR) on Ultrasound | baseline, 1 month, 6 month | PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point. |
| Change in Peak Urinary Flow Rate (Qmax) | Baseline, 1 month, 6 month | Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point. |
| Change in International Index of Erectile Dysfunction (IIEF) | baseline, 1 month, 6 month | IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function. |
| Change in Prostate Volume (PV) | baseline, 1 month, 6 month | Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume. |
Countries
United States
Participant flow
Recruitment details
Patient were recruited in Interventional Radiology clinic from April 2017 to August 2018.
Pre-assignment details
All patients enrolled were treated in the single treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| Prostate Artery Embolization Single arm study of patients undergoing the prostate artery embolization procedure with Embosphere particles.
Embosphere microparticles for prostate artery embolization: Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study closed | 9 |
Baseline characteristics
| Characteristic | Prostate Artery Embolization | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 5 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 3 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Number of Participants With Adverse Events
The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.
Time frame: 12 months
Population: Patients were assessed for adverse events during the time period the study was open
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prostate Artery Embolization | Number of Participants With Adverse Events | 3 Participants |
Secondary
Change in International Index of Erectile Dysfunction (IIEF)
IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.
Time frame: baseline, 1 month, 6 month
Population: Data was not available for 5 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization | Change in International Index of Erectile Dysfunction (IIEF) | 1 month change | -1.3 units on a scale | Standard Deviation 4.7 |
| Prostate Artery Embolization | Change in International Index of Erectile Dysfunction (IIEF) | 6 month change | 3 units on a scale | Standard Deviation 2.8 |
Secondary
Change in International Prostate Symptom Score (IPSS)
International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.
Time frame: baseline, 1 month, 6 month
Population: Data was not available for 1 participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization | Change in International Prostate Symptom Score (IPSS) | 6 month change | 18.8 score on a scale | Standard Deviation 4.6 |
| Prostate Artery Embolization | Change in International Prostate Symptom Score (IPSS) | 1 month change | 16.1 score on a scale | Standard Deviation 4.6 |
Secondary
Change in Peak Urinary Flow Rate (Qmax)
Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.
Time frame: Baseline, 1 month, 6 month
Population: Data was not available for 4 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization | Change in Peak Urinary Flow Rate (Qmax) | 1 month change | 2.4 mL/sec | Standard Deviation 3.5 |
| Prostate Artery Embolization | Change in Peak Urinary Flow Rate (Qmax) | 6 month change | 6 mL/sec | Standard Deviation 6.1 |
Secondary
Change in Post-void Residual (PVR) on Ultrasound
PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.
Time frame: baseline, 1 month, 6 month
Population: Data was not available for 4 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization | Change in Post-void Residual (PVR) on Ultrasound | 1 month change | -32 mL | Standard Deviation 66.5 |
| Prostate Artery Embolization | Change in Post-void Residual (PVR) on Ultrasound | 6 month change | -84.8 mL | Standard Deviation 53.5 |
Secondary
Change in Prostate Volume (PV)
Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.
Time frame: baseline, 1 month, 6 month
Population: Data was not available for 4 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prostate Artery Embolization | Change in Prostate Volume (PV) | 1 month change | -30.7 mL | Standard Deviation 24.1 |
| Prostate Artery Embolization | Change in Prostate Volume (PV) | 6 month change | -7.5 mL | Standard Deviation 13.1 |