Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03239652
• Other study ID #: A-BR-105-055
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2019
• Source: National Cheng-Kung University Hospital
• Contact: Xi-Zhang Lin, MD
• Phone: 886-6-2353535
• Email: linxz[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Lower Urinary Tract Symptom
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Taiwan ACE Beads
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (4)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan, The Industrial Technology Research Institute

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Survival (Safety)	Survival rate was evaluated since treatment day until the date of death or final observation.	An average of 12 weeks.
Secondary	Change on Patient's Symptoms	Change on patients' International Prostate Symptom Score (IPSS)	Before treatment, one and three months after treatment
Secondary	Change on Prostate Volume	Prostate volume measured using MRI	Before treatment, one and three months after treatment.
Secondary	Change in serum Prostate Specific Antigen (PSA) concentration	Measurement of Prostate Specific Antigen in patients undergoing this treatment.	Before treatment, one and three months after treatment.