Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pentosan Polysulfate Sodium 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. |
Drug: Pentosan Polysulfate Sodium 100 MG Oral Capsule
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
Other Names:
|
| Placebo Comparator: Placebo Control 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. |
Drug: Placebo
Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
|
Outcome Measures
Primary Outcome Measures
- Rate of complete remission in lower urinary tract symptoms and hematuria [From date of randomization throughout the treatment period up to 5 years]
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
- Time to complete remission [From date of randomization to study completion up to 5 years]
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
- Time to hematuria recurrence [From date of randomization to study completion up to 5 years]
Time from randomization to recurrence of hematuria
- Assessment of quality of life [From date of randomization to study completion up to 5 years]
Functional Assessment of 36-Item Short Form Survey (SF-36)
- Assessment of symptoms [From date of randomization to study completion up to 5 years]
Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Secondary Outcome Measures
- Duration of hospitalization [From date of randomization to study completion up to 5 years]
Overall days of hospitalization due to radiation cystitis
- Number of invasive procedures [From date of randomization to study completion up to 5 years]
Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.
- Number of adverse events [From date of randomization to study completion up to 5 years]
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.
Eligibility Criteria
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.
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Patients must be ≥20 years of age
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Patients must have received definitive radiation therapy for cancer in pelvic area.
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Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
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Radiation cystitis with lower urinary tract symptoms or hematuria.
Exclusion Criteria:
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Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
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Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
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Abnormal coagulation profile with PT/INR higher than normal
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Thrombocytopenia with platelet counts < 100,000/μL
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Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
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Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts >12,000/μL)
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Patients with known urinary tract infection within 6 months of randomization.
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Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
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Any previous hyperbaric oxygen therapy within 6 months of randomization
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Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
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Has history of thrombocytopenia, hemophilia or bladder cancer
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Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
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Has known history of drug allergy to pentosan polysulfate sodium
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Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- National Taiwan University Hospital
- TCM Biotech International Corporation
Investigators
- Principal Investigator: Chao-Yuan Huang, MD, PhD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202108161MIPD