Clinical Trial evaluating the correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in patients with prostate cancer who relapsed after maximum androgen blockade

Clinical Trial evaluating the correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in patients with prostate cancer who relapsed after maximum androgen blockade - The correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in castration-resistant prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004203

Enrollment

Registered

2017-09-30

Start date

2010-11-01

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

Castration-resistant prostate cancer

Interventions

adding UFT to alternative antiandrogen for patients who relapsed after maximum androgen blockade

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.pathologicaly confirmed prostate cancer 2.relapsed after maximum androgen blockade 3.AWS is confirmed 4.PS(ECOG)0-2 5.life expectancy of at least 3 month 6.general condition is enough and to satisfy the next condition Hb:more than 10.0g/dL WBC:more than 3.000/mm3 and below 12.000/mm3 NEU:more than 2.000/mm3 PLT:more than 100.000/mm3 AST,ALT:under 100IU/L T-Bil:under 1.5mg/dL cre:under 1.5mg/dL nomal ECG 7.specimens obtained by prostate biopsy are available 8.written informed concent 9.ingestion is possible

Exclusion criteria

Exclusion criteria: 1.past history of radiotherapy or prostatectomy 2.past history of allergic reactions 3.use phenytoin 4.contraindication of UFT 5.active infection 6.serious complications 7.other cancer requiring treatment 8.judged inappropriate for the clinical trial by doctor

Design outcomes

Primary

Measure	Time frame
1.PSA response 2.PSA failure free survival	—

Secondary

Measure	Time frame
Safety	—

Countries

Japan

Contacts

Public ContactMasayuki Takahashi

Institute of Health Biosciences, The University of Tokushima Graduate School Department of Urology

takahashi.masayuki@tokushima-u.ac.jp088-633-7159

Outcome results

None listed

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