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Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prostate Artery Embolization

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Prostate Artery Embolization

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed.
Ability to understand and the willingness to sign a written informed consent.
Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months.
Men ≥ 45 years of age
IPSS symptom score ≥ 18 and IPSS bother score ≥ 3
Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a documented negative biopsy within previous 12 months.
For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months.

Exclusion Criteria:

History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
On alpha-blockers within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit and/or part of a Trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR).
On 5-alpha reductase inhibitors within the past 6 months. Unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit
On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks. Unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit.
On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit
Daily use of a pad or device for incontinence required.
Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible)
renal insufficiency (i.e. creatinine > 1.8)
Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
Neurogenic bladder, Hypotonic Bladder
Prior treatment for urinary incontinence
Penile prosthesis.
Artificial urinary sphincter.
Documented bacterial prostatitis within the past year.
Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization.
History of chronic prostatitis within the last 1 year
Known bleeding disorders (e.g. VWD)
Prior prostate procedures (e.g. Transurethral Microwave Therapy (TUMT), Transurethral Needle Ablation of the Prostate (TUNA), Water-induced Thermotherapy (WIT), Transurethral Resection of the Prostate (TURP), Photoselective Vaporization of the Prostate (PVP)
Prior treatment for overactive bladder (e.g. intravesical botox)
Enrolled in another treatment trial for any disease within the past 30 days
Declines or unable to provide informed consent
Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression.
A history of rectal malignancy
Prior surgical prostate intervention
Interest in future fertility
Allergy to iodinated contrast agents not responsive to steroid premedication regimen
Contraindication to conscious sedation

Sites / Locations

Northwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate Artery Embolization

Arm Description

There is only one arm of this study where patients receive Prostate Artery Embolization

Outcomes

Primary Outcome Measures

Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .

The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death.

Secondary Outcome Measures

Change in International Prostate Symptom Score (IPSS)

Questionnaire- IPSS has 7 questions. Answer choices are as follows. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. Scores can range from 0-35 with 0 being the better outcome and 35 the worst outcome. Question 1-6 0-Not at all Less than 1 time in 5 Less than half the time About half the time More than half the time Almost always Question 7 0-None 1-1 time 2-2 times 3-3 times 4-4 times 5-5 or more times

Change in Quality of Life (QOL) Bother Score

The total score ranges from 0-6 with 0 being the best outcome and 6 being the worst outcome. Questionnaire- answers choices are as follows: 0- Delighted Pleased Mostly Satisfied Mixed about equality satisfied and dissatisfied Mostly Dissatisfied Unhappy Terrible

Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score

The BPH Impact Index is to assess the impact of BPH symptoms on patient health and functioning. It is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.The BII is an evaluative index useful in measuring the magnitude of change in the impact of BPH-LUTS within a person over time. Scores range from 0-13 with 0 being the best outcome and 13 being the worst. Questionnaire- consists of 4 questions; answer choices are as follows Question 1: 0-none, 1-only a little, 2-some, 3-a lot Question 2: 0-none, 1-only a little, 2-some, 3-a lot Question 3: 0-not at all bothersome, 1- bothers me a little, 2-bothers me some, 3-bothers me a lot Question 4: 0-none of the time, 1- a little of the time, 2- some of the time, 3-most of the time, 4-all of the time

Change in Peak Urine Flow (Qmax)

Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements

Full Information

NCT ID

NCT03052049

First Posted

February 8, 2017

Last Updated

October 5, 2023

Sponsor

Northwestern University

Collaborators

BTG International Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03052049

Brief Title

Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

Official Title

Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 6, 2017 (Actual)

Primary Completion Date

September 26, 2022 (Actual)

Study Completion Date

September 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

BTG International Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).

Detailed Description

This pilot study will be a single center, open labeled, non-randomized feasibility study to evaluate the initial safety of PAE for the treatment of symptomatic bladder outlet obstruction. 30 adult male subjects will be enrolled in this study. If eligible patients will undergo the prostate artery embolization procedure in the Interventional Radiology department. An angiogram of the prostate arteries will be done. Small beads called Bead Block microspheres will be injected into the prostate artery to slow blood flow to the prostate in the hope of providing relief with minimal side effects and complications, for lower urinary tract symptoms caused by BPH. After the procedure the patient will be followed at 4 weeks, 12 weeks, 6 months, and 12 months post procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia (BPH)

Keywords

Prostate Artery Embolization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prostate Artery Embolization

Arm Type

Experimental

Arm Description

There is only one arm of this study where patients receive Prostate Artery Embolization

Intervention Type

Device

Intervention Name(s)

Prostate Artery Embolization

Other Intervention Name(s)

The interventional type is a procedure

Intervention Description

The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.

Primary Outcome Measure Information:

Title

Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change in International Prostate Symptom Score (IPSS)

Description

Time Frame

Baseline, 1, 3, 6, 12 months post procedure

Title

Change in Quality of Life (QOL) Bother Score

Description

Time Frame

Baseline, 1, 3, 6, 12 months post procedure

Title

Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score

Description

Time Frame

Baseline, 1, 3, 6, 12 months post procedure

Title

Change in Peak Urine Flow (Qmax)

Description

Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements

Time Frame

Baseline, 1, 3, 6, and 12 months post procedure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed. Ability to understand and the willingness to sign a written informed consent. Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months. Men ≥ 45 years of age IPSS symptom score ≥ 18 and IPSS bother score ≥ 3 Peak flow rate Qmax≤ 12 with voided volume ≥125 cc For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a documented negative biopsy within previous 12 months. For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months. Exclusion Criteria: History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, On alpha-blockers within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit and/or part of a Trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR). On 5-alpha reductase inhibitors within the past 6 months. Unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks. Unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit. On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit Daily use of a pad or device for incontinence required. Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible) renal insufficiency (i.e. creatinine > 1.8) Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function. Neurogenic bladder, Hypotonic Bladder Prior treatment for urinary incontinence Penile prosthesis. Artificial urinary sphincter. Documented bacterial prostatitis within the past year. Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization. History of chronic prostatitis within the last 1 year Known bleeding disorders (e.g. VWD) Prior prostate procedures (e.g. Transurethral Microwave Therapy (TUMT), Transurethral Needle Ablation of the Prostate (TUNA), Water-induced Thermotherapy (WIT), Transurethral Resection of the Prostate (TURP), Photoselective Vaporization of the Prostate (PVP) Prior treatment for overactive bladder (e.g. intravesical botox) Enrolled in another treatment trial for any disease within the past 30 days Declines or unable to provide informed consent Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease) Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression. A history of rectal malignancy Prior surgical prostate intervention Interest in future fertility Allergy to iodinated contrast agents not responsive to steroid premedication regimen Contraindication to conscious sedation

Overall Study Officials: