Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Radiation Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245591
• Other study ID #: 202108161MIPD
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 29, 2022
• Est. completion date: November 1, 2029

Study information

• Verified date: January 2022
• Source: National Taiwan University Hospital
• Contact: Chi-Shin Tseng, MD
• Phone: +886223123456
• Email: clifford1987tcs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 1, 2029
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Radiation Cystitis

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	TCM Biotech International Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From date of randomization throughout the treatment period up to 5 years
Primary	Time to complete remission	Time from randomization to complete remission of lower urinary tract syndromes and hematuria	From date of randomization to study completion up to 5 years
Primary	Time to hematuria recurrence	Time from randomization to recurrence of hematuria	From date of randomization to study completion up to 5 years
Primary	Assessment of quality of life	Functional Assessment of 36-Item Short Form Survey (SF-36)	From date of randomization to study completion up to 5 years
Primary	Assessment of symptoms	Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)	From date of randomization to study completion up to 5 years
Secondary	Duration of hospitalization	Overall days of hospitalization due to radiation cystitis	From date of randomization to study completion up to 5 years
Secondary	Number of invasive procedures	Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.	From date of randomization to study completion up to 5 years
Secondary	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.	From date of randomization to study completion up to 5 years