Clinical study to evaluate the effectiveness of rectal culture before prostate biopsy to prevent postoperative bacterial prostatitis, multicenter, randomized controlled trial in Japan

Clinical study to evaluate the effectiveness of rectal culture before prostate biopsy to prevent postoperative bacterial prostatitis, multicenter, randomized controlled trial in Japan - PROJECT trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039478

Enrollment

5000

Registered

2020-02-14

Start date

2020-04-01

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

acute bacterial prostatitis

Interventions

arm using selective media for rectal cultoure Culture from rectal swab is evaluated before prostate biopsy. If resistant bacteria are confirmed, piperacin/tazobactam 4.5g will administered 30 minutes

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Patients who are scheduled for transrectal prostate biopsy with suspected prostate cancer. 2. Written informed consent

Exclusion criteria

Exclusion criteria: 1, High risk for infection Prostate volume 75ml over Diabetes mellitus Patients receiving steroids Severe lower urinary tract symptoms Immunodeficiency 2, Transperineal prostate biopsy

Design outcomes

Primary

Measure	Time frame
Incidence rate of acute bacterial prostatitis.	—

Secondary

Measure	Time frame
Sensitivity and specificity of simple medium, severity at the onset of prostatitis.	—

Countries

Japan

Contacts

Public ContactYuki Maruyama

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science Urology

eat.the.lobster@gmail.com086-235-7287

Outcome results

None listed

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