Clinical trial NCT03052049: 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
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Prostate Artery Embolization
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2017-02-14
Enrollment: 28
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .
timeFrame: 1 year
Secondary outcomes:
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Baseline, 1, 3, 6, 12 months post procedure
measure: Change in Quality of Life (QOL) Bother Score
timeFrame: Baseline, 1, 3, 6, 12 months post procedure
measure: Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score
timeFrame: Baseline, 1, 3, 6, 12 months post procedure
measure: Change in Peak Urine Flow (Qmax)
timeFrame: Baseline, 1, 3, 6, and 12 months post procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern
state: Illinois
Study officials:
affiliation: Northwestern University
name: Riad Salem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Matthias Hofer, MD
role: STUDY_CHAIR
affiliation: Northwestern University
name: Bartley Thornburg, MD
role: STUDY_CHAIR
affiliation: Northwestern University
name: Kush Desai, MD
role: STUDY_CHAIR
affiliation: Northwestern University
name: Ahsun Riaz, MD
role: STUDY_CHAIR
affiliation: Northwestern University
name: Samdeep Mouli, MD
role: STUDY_CHAIR
References: