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Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT03239652
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptom Benign Prostatic Hyperplasia (BPH) Device: Taiwan ACE Beads Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Taiwan ACE Beads microspheres
The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.
Device: Taiwan ACE Beads
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.




Primary Outcome Measures :
  1. Patients Survival (Safety) [ Time Frame: An average of 12 weeks. ]
    Survival rate was evaluated since treatment day until the date of death or final observation.


Secondary Outcome Measures :
  1. Change on Patient's Symptoms [ Time Frame: Before treatment, one and three months after treatment ]
    Change on patients' International Prostate Symptom Score (IPSS)

  2. Change on Prostate Volume [ Time Frame: Before treatment, one and three months after treatment. ]
    Prostate volume measured using MRI

  3. Change in serum Prostate Specific Antigen (PSA) concentration [ Time Frame: Before treatment, one and three months after treatment. ]
    Measurement of Prostate Specific Antigen in patients undergoing this treatment.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239652


Contacts
Contact: Xi-Zhang Lin, MD 886-6-2353535 ext 6202/3624 linxz@mail.ncku.edu.tw
Contact: Hui-Yu Hung, Bachelor 886-6-2353535 ext 6202/3624 z9908033@email.ncku.edu.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Xi-Zhang Lin, MD    886-6-2353535 ext 3624    linxz@mail.ncku.edu.tw   
Contact: Hui-Yu Hung, Bachelor    886-6-2353535 ext 3624    z9908033@email.ncku.edu.tw   
Principal Investigator: Yuh-Shyan Tsai, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
Investigators
Principal Investigator: Yuh-Shyan Tsai, MD Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan

Publications of Results:
Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03239652     History of Changes
Other Study ID Numbers: A-BR-105-055
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Cheng-Kung University Hospital:
Microsphere
Transcatheter Arterial chemo-embolization

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms