Clinical trial NCT03239652: Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
Official title: Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptom
Benign Prostatic Hyperplasia (BPH)
Keywords: Microsphere
Transcatheter Arterial chemo-embolization
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: The Industrial Technology Research Institute
name: National Cheng Kung University
name: National Research Program for Biopharmaceuticals, Taiwan
First posted: 2017-08-04
Enrollment: 12
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).

Detailed description: T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial, we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic hyperplasia patients, which is beneficial to the participants in precise medicine as well as in the pharmaceutical and medical device industry.

Eligibility criteria: Inclusion Criteria:

A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.

B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score \> 12 with mild to severe symptom of LUTS.

C. Prostate volume \> 50 mL.

D. Urinary flow rate \<15 mL / sec.

E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate.

Exclusion Criteria:

If patients meet any of the following criteria they may not be entered into the study:

A. Major pelvic disease, or other malignancies.

B. Prostate specific antigen of serum \> 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA\>10 ng/mL).

C. Had Prostate surgery.

D. Chronic bacterial prostatitis.

E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.

F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.

G. White Blood Cell\< 2000 or Severe thrombocytopenia（Platelet count \<50,000/μL)，or blood coagulation abnormalities uncorrectable .

H. Unable to follow-up by MRI 3 times.

I. Unable to follow-up by ultrasound or CT scan.

J. Unwilling to sign a written informed consent form.

K. Allergic to Iodine or other injections.

L. Acute bacterial prostatitis.

M. Patients with active urinary tract infections or recurrent urinary tract infections (\>2/years), prostatitis, or interstitial cystitis.

N. Cases of biopsy proven prostate, bladder, or urethral cancer.

O. Patients with glomerular filtration rates less than 40 who are not already on dialysis.

P. Patients with bilateral internal iliac arterial occlusion.

Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc).

R. Patients with neurogenic or bladder atonia.

S. Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue.

T. Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).

U. Patients with urethral stents.

V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery.

W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization.

X. Allergic to pharmaceutical excipients related to Microspheres.

Primary outcomes:
measure: Patients Survival (Safety)
timeFrame: An average of 12 weeks.
Secondary outcomes:
measure: Change on Patient's Symptoms
timeFrame: Before treatment, one and three months after treatment
measure: Change on Prostate Volume
timeFrame: Before treatment, one and three months after treatment.
measure: Change in serum Prostate Specific Antigen (PSA) concentration
timeFrame: Before treatment, one and three months after treatment.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan
name: Yuh-Shyan Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
citation: Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.