NCT03239652

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 17, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

July 25, 2017

Last Update Submit

October 15, 2019

Conditions

Lower Urinary Tract SymptomBenign Prostatic Hyperplasia (BPH)

Keywords

MicrosphereTranscatheter Arterial chemo-embolization

Outcome Measures

Primary Outcomes (1)

  • Patients Survival (Safety)

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

    An average of 12 weeks.

Secondary Outcomes (3)

  • Change on Patient's Symptoms

    Before treatment, one and three months after treatment

  • Change on Prostate Volume

    Before treatment, one and three months after treatment.

  • Change in serum Prostate Specific Antigen (PSA) concentration

    Before treatment, one and three months after treatment.

Study Arms (1)

Taiwan ACE Beads microspheres

EXPERIMENTAL

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

Device: Taiwan ACE Beads

Interventions

Taiwan ACE BeadsDEVICE

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

Taiwan ACE Beads microspheres

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Related 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.

    PMID: 26339465RESULT

  • 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.

    PMID: 27146488RESULT

MeSH Terms

Conditions

Lower Urinary Tract SymptomsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yuh-Shyan Tsai, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi-Zhang Lin, MD

CONTACT

886-6-2353535linxz@mail.ncku.edu.tw

Hui-Yu Hung, Bachelor

CONTACT

886-6-2353535z9908033@email.ncku.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 4, 2017

Study Start

January 1, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 17, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)