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Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

Primary Purpose

Lower Urinary Tract Symptom, Benign Prostatic Hyperplasia (BPH)

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Taiwan ACE Beads

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptom focused on measuring Microsphere, Transcatheter Arterial chemo-embolization

Eligibility Criteria

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

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.

Sites / Locations

National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Taiwan ACE Beads microspheres

Arm Description

The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.

Outcomes

Primary Outcome Measures

Patients Survival (Safety)

Survival rate was evaluated since treatment day until the date of death or final observation.

Secondary Outcome Measures

Change on Patient's Symptoms

Change on patients' International Prostate Symptom Score (IPSS)

Change on Prostate Volume

Prostate volume measured using MRI

Change in serum Prostate Specific Antigen (PSA) concentration

Measurement of Prostate Specific Antigen in patients undergoing this treatment.

Full Information

NCT ID

NCT03239652

First Posted

July 25, 2017

Last Updated

October 15, 2019

Sponsor

National Cheng-Kung University Hospital

Collaborators

The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03239652

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

Collaborators

The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Lower Urinary Tract Symptom, Benign Prostatic Hyperplasia (BPH)

Keywords

Microsphere, Transcatheter Arterial chemo-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

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Taiwan ACE Beads microspheres

Arm Type

Experimental

Arm Description

The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.

Intervention Type

Device

Intervention Name(s)

Taiwan ACE Beads

Intervention Description

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

Primary Outcome Measure Information:

Title

Patients Survival (Safety)

Description

Survival rate was evaluated since treatment day until the date of death or final observation.

Time Frame

An average of 12 weeks.

Secondary Outcome Measure Information:

Title

Change on Patient's Symptoms

Description

Change on patients' International Prostate Symptom Score (IPSS)

Time Frame

Before treatment, one and three months after treatment

Title

Change on Prostate Volume

Description

Prostate volume measured using MRI

Time Frame

Before treatment, one and three months after treatment.

Title

Change in serum Prostate Specific Antigen (PSA) concentration

Description

Measurement of Prostate Specific Antigen in patients undergoing this treatment.

Time Frame

Before treatment, one and three months after treatment.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xi-Zhang Lin, MD

Phone

886-6-2353535

Ext

6202/3624

linxz@mail.ncku.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Hui-Yu Hung, Bachelor

Phone

886-6-2353535

Ext

6202/3624

z9908033@email.ncku.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuh-Shyan Tsai, MD

Organizational Affiliation

Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng Kung University Hospital

City

Tainan

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xi-Zhang Lin, MD

Phone

886-6-2353535

Ext

3624

linxz@mail.ncku.edu.tw

First Name & Middle Initial & Last Name & Degree

Hui-Yu Hung, Bachelor

Phone

886-6-2353535

Ext

3624

z9908033@email.ncku.edu.tw

First Name & Middle Initial & Last Name & Degree

Yuh-Shyan Tsai, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26339465

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.

Results Reference

result

PubMed Identifier

27146488

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.

Results Reference

result

Learn more about this trial

Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

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