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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
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 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGRate 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
Time frame: 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
Time frame: From date of randomization to study completion up to 5 years
Time to hematuria recurrence
Time from randomization to recurrence of hematuria
Time frame: 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)
Time frame: 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)
Time frame: From date of randomization to study completion up to 5 years
Duration of hospitalization
Overall days of hospitalization due to radiation cystitis
Time frame: From date of randomization to study completion up to 5 years
Number of invasive procedures
Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.
Time frame: From date of randomization to study completion up to 5 years
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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.
Time frame: From date of randomization to study completion up to 5 years