Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03239652

Collaborator

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

Enrollment

Location

Arm

41.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptom Benign Prostatic Hyperplasia (BPH)	Device: Taiwan ACE Beads	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

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 :

Jan 1, 2017

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patients Survival (Safety) [An average of 12 weeks.]
Survival rate was evaluated since treatment day until the date of death or final observation.

Secondary Outcome Measures

Change on Patient's Symptoms [Before treatment, one and three months after treatment]
Change on patients' International Prostate Symptom Score (IPSS)
Change on Prostate Volume [Before treatment, one and three months after treatment.]
Prostate volume measured using MRI
Change in serum Prostate Specific Antigen (PSA) concentration [Before treatment, one and three months after treatment.]
Measurement of Prostate Specific Antigen in patients undergoing this treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS.
Prostate volume > 50 mL.
Urinary flow rate <15 mL / sec.
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:

Major pelvic disease, or other malignancies.
Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL).
Had Prostate surgery.
Chronic bacterial prostatitis.
Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.
Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood coagulation abnormalities uncorrectable .
Unable to follow-up by MRI 3 times.
Unable to follow-up by ultrasound or CT scan.
Unwilling to sign a written informed consent form.
Allergic to Iodine or other injections.
Acute bacterial prostatitis.
Patients with active urinary tract infections or recurrent urinary tract infections (>2/years), prostatitis, or interstitial cystitis.
Cases of biopsy proven prostate, bladder, or urethral cancer.
Patients with glomerular filtration rates less than 40 who are not already on dialysis.
Patients with bilateral internal iliac arterial occlusion.
Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc).
Patients with neurogenic or bladder atonia.
Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue.
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.).
Patients with urethral stents.
Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery.
Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization.
Allergic to pharmaceutical excipients related to Microspheres.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University Hospital	Tainan		Taiwan

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