A study to evaluate efficacy and safety of docetaxel combined with dexamethasone in patients with hormone refractory prostate cancer; JMTO PCa10-01

A study to evaluate efficacy and safety of docetaxel combined with dexamethasone in patients with hormone refractory prostate cancer; JMTO PCa10-01 - A study of docetaxel and dexamethason for hormone refractory prostate cancer; JMTO PCa10-01

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004096

Enrollment

Registered

2010-09-01

Start date

2010-09-01

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

prostate cancer

Interventions

Docetaxel 75 mg/m2 i.v. q3w, up to 10 cycles + dexamethason 1.0 mg/day p.o. daily.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Advanced or recurrent prostate cancer during or after surgical or medical castration. 2. ECOG performance status: 0 or 1. 3. Adequate organ functions: ; Neutrophils:;1,500/mm3. ; WBC:;3,000/mm3. ; Platelets: ;75,000/mm3. ; Hemoglobin:;9.0g/dL. ; AST: <2.5x Upper limit of normal (ULN). ; ALT: <2.5x ULN. ; Total bililbine: <ULN. ; Serum creatinine: <1.5x ULN. 4. Acceptable sufficient contraception. 5. Age:;20 years old at the time of enrollment. 6. Obtaining written informed consent.

Exclusion criteria

Exclusion criteria: 1. No prior cyto-toxic chemotherapy and/or molecular targeting therapy, including mono-therapy of estramustine. 2. Infection. 3. Fever with suspicion of infectious disease. 4. Interstitial pneumonitis and pulmonary fibrosis.

Design outcomes

Primary

Measure	Time frame
PSA response defined as a reduction in serum PSA levels of at least 50%	—

Secondary

Measure	Time frame
Safety, PSA flare, time to PSA failure	—

Countries

Japan

Contacts

Public ContactNobumichi Tanaka

Nara Medical University Department of Urology

sendo@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

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