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Recruiting NCT05245591

Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Phase II / Phase III Interventional Radiation Cystitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pentosan Polysulfate Sodium 100 MG Oral Capsule, Placebo.
Who it may be relevant to
Registry conditions: Radiation Cystitis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis

Overview

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).

Interventions

  • 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
  • Drug Placebo
    Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks

Primary outcome measures

  • Rate of complete remission in lower urinary tract symptoms and hematuria [Time frame: From date of randomization throughout the treatment period up to 5 years]
  • Time to complete remission [Time frame: From date of randomization to study completion up to 5 years]
  • Time to hematuria recurrence [Time frame: From date of randomization to study completion up to 5 years]
  • Assessment of quality of life [Time frame: From date of randomization to study completion up to 5 years]
  • Assessment of symptoms [Time frame: From date of randomization to study completion up to 5 years]
Secondary outcome measures (3)
  • Duration of hospitalization [Time frame: From date of randomization to study completion up to 5 years]
  • Number of invasive procedures [Time frame: From date of randomization to study completion up to 5 years]
  • Number of adverse events [Time frame: From date of randomization to study completion up to 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT05245591 · 202108161MIPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗