Clinical trial NCT05245591: 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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Radiation Cystitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: TCM Biotech International Corporation
First posted: 2022-02-18
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients must be ≥20 years of age
3. Patients must have received definitive radiation therapy for cancer in pelvic area.
4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
5. Radiation cystitis with lower urinary tract symptoms or hematuria.

Exclusion Criteria:

1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
3. Abnormal coagulation profile with PT/INR higher than normal
4. Thrombocytopenia with platelet counts \< 100,000/μL
5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts \>12,000/μL)
7. Patients with known urinary tract infection within 6 months of randomization.
8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
9. Any previous hyperbaric oxygen therapy within 6 months of randomization
10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
11. Has history of thrombocytopenia, hemophilia or bladder cancer
12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
13. Has known history of drug allergy to pentosan polysulfate sodium
14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma

Primary outcomes:
measure: Rate of complete remission in lower urinary tract symptoms and hematuria
timeFrame: From date of randomization throughout the treatment period up to 5 years
measure: Time to complete remission
timeFrame: From date of randomization to study completion up to 5 years
measure: Time to hematuria recurrence
timeFrame: From date of randomization to study completion up to 5 years
measure: Assessment of quality of life
timeFrame: From date of randomization to study completion up to 5 years
measure: Assessment of symptoms
timeFrame: From date of randomization to study completion up to 5 years
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: From date of randomization to study completion up to 5 years
measure: Number of invasive procedures
timeFrame: From date of randomization to study completion up to 5 years
measure: Number of adverse events
timeFrame: From date of randomization to study completion up to 5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chao-Yuan Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: