Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia

Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia - Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010585

Enrollment

300

Registered

2013-06-01

Start date

2013-06-01

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

Benign hyperplasia, prostate cancer

Interventions

Oral administration of dutasteride for once negative biopsy patients and re-biopsy after begining of dutasteride for a year

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: PSA level of over than 4ng/ml Men had one negative prostate biopsy Men had a benign prostate hyperplasia including criteria of PV>30ml and IPSS> 8-points.

Exclusion criteria

Exclusion criteria: Men had a prostatis before a half of year Men had surgery of prostate before enrollment Men took dutasteride, finasteride, prostal which were reduced prostate volume. Men had high grade intraepithelial neoplasia, atypical small acinar proliferation on one prostate biopsy Men are inappropriately decided by a doctor

Design outcomes

Primary

Measure	Time frame
Detection of prostate cancer	—

Secondary

Measure	Time frame
Flucturation of PSA Change of prostate volume QOL Adverse event	—

Countries

Japan

Contacts

Public ContactTakaaki Inoue

Kansai Medical University The department of urology and andrology

inouetak@hirakata.kmu.ac.jp06-6992-1001

Outcome results

None listed

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