Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

NCT05245591 | Recruiting Phase 2 DMC

• 1 other identifier: 202108161MIPD
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Cystitis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Time to hematuria recurrence

  Time from randomization to recurrence of hematuria

  From date of randomization to study completion up to 5 years

• 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

• 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 Outcomes (3)

• Duration of hospitalization

  From date of randomization to study completion up to 5 years

• Number of invasive procedures

  From date of randomization to study completion up to 5 years

• Number of adverse events

  From date of randomization to study completion up to 5 years

Study Arms (2)

Pentosan Polysulfate Sodium

EXPERIMENTAL

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

Placebo Control

PLACEBO COMPARATOR

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

Interventions

Pentosan Polysulfate Sodium 100 MG Oral Capsule DRUG

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

Also known as: Urosan, ELMIRON, PPS

Pentosan Polysulfate Sodium

Placebo DRUG

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

Placebo Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• TCM Biotech International Corporation: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Pentosan Sulfuric Polyester

Intervention Hierarchy (Ancestors)

Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Organic Chemicals; Polysaccharides; Carbohydrates

Study Officials

• Chao-Yuan Huang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Shin Tseng, MD

CONTACT

+886223123456; clifford1987tcs@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 18, 2022
• Study Start: April 29, 2022
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)