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 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 prostatectomy - Intraoperative photodynamic diagnosis of prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011770

Enrollment

Registered

2013-09-14

Start date

2011-06-01

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 was administrated orally (1.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patient who has localized prostate cancer indicated for prostatectomy (open surgery, laparoscopic surgery or robot-assisted surgery)

Exclusion criteria

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

Hiroshima University Department of Urology

urology@hiroshima-u.ac.jp082-257-5242

Outcome results

None listed

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