Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

National Taiwan University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Radiation Cystitis

Treatments: Drug: Placebo; Drug: Pentosan Polysulfate Sodium 100 MG Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05245591

202108161MIPD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Pentosan Polysulfate Sodium

Experimental group

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.

Treatment:

Drug: Pentosan Polysulfate Sodium 100 MG Oral Capsule

Placebo Control

Placebo Comparator group

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.

Treatment:

Drug: Placebo