Back to resultsRadiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Primary Purpose
Radiation Cystitis
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Pentosan Polysulfate Sodium 100 MG Oral Capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Cystitis
Eligibility Criteria
Inclusion Criteria:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
- Patients must be ≥20 years of age
- Patients must have received definitive radiation therapy for cancer in pelvic area.
- Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
- Radiation cystitis with lower urinary tract symptoms or hematuria.
Exclusion Criteria:
- Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
- Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
- Abnormal coagulation profile with PT/INR higher than normal
- Thrombocytopenia with platelet counts < 100,000/μL
- Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
- Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts >12,000/μL)
- Patients with known urinary tract infection within 6 months of randomization.
- Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
- Any previous hyperbaric oxygen therapy within 6 months of randomization
- Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
- Has history of thrombocytopenia, hemophilia or bladder cancer
- Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
- Has known history of drug allergy to pentosan polysulfate sodium
- Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pentosan Polysulfate Sodium
Placebo Control
Arm Description
U101 is available as a capsule containing 100 milligrams (mg) of pentosan polysulfate sodium. Subjects will be administered U101 at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study.
Placebo to match U101 is available as a capsule in 100 milligrams (mg). Subjects will be administered placebo at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study.
Outcomes
Primary Outcome Measures
Rate of complete remission in lower urinary tract symptoms and hematuria
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
Time to complete remission
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
Time to hematuria recurrence
Time from randomization to recurrence of hematuria
Assessment of quality of life
Functional Assessment of 36-Item Short Form Survey (SF-36)
Assessment of symptoms
Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Secondary Outcome Measures
Duration of hospitalization
Overall days of hospitalization due to radiation cystitis
Number of invasive procedures
Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.
Number of adverse events
Percentage of patients with any adverse event (AE), adverse event (AE) leading to study drug discontinuation, serious adverse event (SAE), and adverse event (AE) related to study drug.
Full Information
NCT ID
NCT05245591
First Posted
January 23, 2022
Last Updated
May 2, 2022
Sponsor
National Taiwan University Hospital
Collaborators
TCM Biotech International Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05245591
Brief Title
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Official Title
A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
TCM Biotech International Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.
Detailed Description
RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region.
Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pentosan Polysulfate Sodium
Arm Type
Experimental
Arm Description
U101 is available as a capsule containing 100 milligrams (mg) of pentosan polysulfate sodium. Subjects will be administered U101 at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Placebo to match U101 is available as a capsule in 100 milligrams (mg). Subjects will be administered placebo at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study.
Intervention Type
Drug
Intervention Name(s)
Pentosan Polysulfate Sodium 100 MG Oral Capsule
Other Intervention Name(s)
Urosan, ELMIRON, PPS
Intervention Description
Pentosan Polysulfate Sodium 100 mg three times daily (tid) for 0-8 weeks Pentosan Polysulfate Sodium 100 mg twice daily (bid) for 9-16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
Primary Outcome Measure Information:
Title
Rate of complete remission in lower urinary tract symptoms and hematuria
Description
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
Time Frame
From date of randomization throughout the treatment period up to 5 years
Title
Time to complete remission
Description
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
Time Frame
From date of randomization to study completion up to 5 years
Title
Time to hematuria recurrence
Description
Time from randomization to recurrence of hematuria
Time Frame
From date of randomization to study completion up to 5 years
Title
Assessment of quality of life
Description
Functional Assessment of 36-Item Short Form Survey (SF-36)
Time Frame
From date of randomization to study completion up to 5 years
Title
Assessment of symptoms
Description
Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Time Frame
From date of randomization to study completion up to 5 years
Secondary Outcome Measure Information:
Title
Duration of hospitalization
Description
Overall days of hospitalization due to radiation cystitis
Time Frame
From date of randomization to study completion up to 5 years
Title
Number of invasive procedures
Description
Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.
Time Frame
From date of randomization to study completion up to 5 years
Title
Number of adverse events
Description
Percentage of patients with any adverse event (AE), adverse event (AE) leading to study drug discontinuation, serious adverse event (SAE), and adverse event (AE) related to study drug.
Time Frame
From date of randomization to study completion up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
Patients must be ≥20 years of age
Patients must have received definitive radiation therapy for cancer in pelvic area.
Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
Radiation cystitis with lower urinary tract symptoms or hematuria.
Exclusion Criteria:
Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
Abnormal coagulation profile with PT/INR higher than normal
Thrombocytopenia with platelet counts < 100,000/μL
Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts >12,000/μL)
Patients with known urinary tract infection within 6 months of randomization.
Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
Any previous hyperbaric oxygen therapy within 6 months of randomization
Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
Has history of thrombocytopenia, hemophilia or bladder cancer
Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
Has known history of drug allergy to pentosan polysulfate sodium
Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Shin Tseng, MD
Phone
+886223123456
Email
clifford1987tcs@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao-Yuan Huang, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao-Yuan Huang, phD
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
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