Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy

Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy - Intraoperative photodynamic diagnosis of prostate cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003251

Enrollment

330

Registered

2010-02-24

Start date

2010-03-01

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

Localized prostate cancer

Interventions

Three to four hours prior to operation 1.0g 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 5% glucose solution and 8.4% sodium hydrogen car

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patient who has localized prostate cancer indicated for radical prostatectomy (open surgery or laparoscopic surgery)

Exclusion criteria

Exclusion criteria: Patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results.	—

Secondary

Measure	Time frame
Safety:The occurrence frequency and degree of adverse event were investigated through the procedures.	—

Countries

Japan

Contacts

Public ContactKeiji Inoue

Kochi Medical School Department of Urology, Kochi Medical School

keiji@kochi-u.ac.jp088-880-2402

Outcome results

None listed

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