Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Prostatic Hyperplasia, Benign Clinical Trial

Official title:

Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055624
• Other study ID #: 161719
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 18, 2019

Study information

• Verified date: March 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Enlarged Prostate With Lower Urinary Tract Symptoms
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia
• Prostatic Hyperplasia, Benign

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months
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.	baseline, 1 month, 6 month
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.	baseline, 1 month, 6 month
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.	Baseline, 1 month, 6 month
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.	baseline, 1 month, 6 month
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.	baseline, 1 month, 6 month