Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment

Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment - Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004861

Enrollment

260

Registered

2011-01-12

Start date

2010-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle invasive bladder cancer (pTa-1, G1-2)

Interventions

Pirarubicin (THP) at 30 mg will be infused into the urinary bladder for about 30 minutes within 24 hours after TUR-Bt in both groups. Group A: The course will be observed. Group B: THP at 30 mg wil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Non-muscle invasive bladder cancer (pTa-1,G1-2). (2) Patients who can periodically undergo cystoscopic diagnosis of recurrence after surgery. (3) Curative resection of all visible tumors can be performed. (4) Agreement form for this study should be obtained from the patient.

Exclusion criteria

Exclusion criteria: (1) Patients who previously underwent intravesical infusion therapy with BCG. (2) Patients who underwent maintenance intravesical infusion therapy with anticancer drugs within 1 year. (3) Patients with history or present disease of upper urinary tract utotherial carcinoma. (4) Patients with duplex of active other malignant disease. (5) Function of all organs are without severe dysfunction. (6) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
Recurrence-free rate (survival period and rate) (investigation in all patients, by risk (low and intermediate), and time (at 1, 2, and 3 years))	—

Secondary

Measure	Time frame
Safety	—

Countries

Japan

Contacts

Public ContactKazuya Mikami

Kyoto Prefectural University of Medicine Department of Urology

info@kpum-urology.jp075-251-5595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026