Clinical effect of Eviprostat in patients with high levels of PSA

Clinical effect of Eviprostat in patients with high levels of PSA - Clinical effect of Eviprostat in patients with high levels of PSA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002126

Enrollment

200

Registered

2009-06-26

Start date

2009-06-01

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

patients with high levels of PSA

Interventions

Three tablets of Eviprostat three times per day for 12 months no medication

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. age >=40 2. Written informed consent 3. serum PSA levels >=4.0 4. Patients without prostate cancer 5. Patients with lower urinary tract symptoms

Exclusion criteria

Exclusion criteria: 1) patients with prostate cancer 2) patients with previous operation on prostate 3) Subjects taking any anti-androgen drugs 4) patients with prostatitis 5) Subjects with active urinary infection 6) Subjects with urethral catheter 7) Subjects with irritation to Eviprostat 8) Severe renal dysfunction 9) Severe liver dysfunction 10) Other ineligible subjects

Design outcomes

Primary

Measure	Time frame
Histological changes of prostate inflammation in prostate biopsy will be examined between before and after the intake of Eviprostat for 12 months. Inflammation is assessed across all scores and the amount of inflammation scored as none (0), mild (1), moderate (2), or marked (3).	—

Countries

Japan

Contacts

Public ContactHiroshi Fukuhara

University of Tokyo Hospital Department of Uology

Outcome results

None listed

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