Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer

Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer - Recurrence preventive effect of a single immediate postoperative prophylactic intravesical instillation with Pirarubicin for non-muscle invasive bladder cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011441

Enrollment

700

Registered

2013-08-10

Start date

2013-05-09

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

Interventions

intravesical instillation of pirarubicin 30mg within 24 hours after TURBT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Non-muscle invasive bladder cancer whom central pathology has diagnosis (2) Curative resection of all visible tumors can be performed. (3) Sufficient organ functions. (4) ECOG performance status (PS) of 0,1 or 2 (5) 20years old and over (6) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Not undergoing TURBT (2) Target at 2ndTUR or BCG therapy (3) Patients with historically or presently disease of upper urinary tract urothelial cell carcinoma. (4) Presence of risk perforans bladder or rebleeding by wide TURBT (5) Presence of active other cancers. (6) Funcion of all organs are without severe dysfunction. (7) Lymph node metastasis or ogan metastasis (8) After TURBT,patients didn`t undergo intravesical therapy with pirarubicin. (9) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
The period from a 1st TURBT to the 1st recurrence (Duration of primary recurrence-free survival)	—

Secondary

Measure	Time frame
The period from a 1st TURBT to the 2nd recurrence The period from a 2nd TURBT to the 2nd recurrence Safety	—

Countries

Japan

Contacts

Public ContactMotohide Uemura

Osaka University Graduate School of Medicine Department of Organ Specific Regulation (Urology)

81668793531

Outcome results

None listed

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