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A randomised clinical trial of docetaxel and estrogen in patients with castration resistant prostate cancer

A randomised clinical trial of docetaxel and estrogen in patients with castration resistant prostate cancer - Docetaxel and Estrogen in CRPC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006120
Enrollment
80
Registered
2011-09-01
Start date
2011-08-01
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

Chemotherapy: Docetaxel 70mg/m2 div. every 4 weeks. Predonisolone 10mg/day p.o. daily. Hormonal therapy: Ethynil estradiol 1.0mg/day p.o. daily.

Sponsors

Department of Nephro-Urology, Nagasaki University Graduate School of Biomedical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed as prostate cancer pathologically at the initial treatment. 2)Clinical any T any N any M prostate cancer patient treated by androgen deprivation therapy prior to this trial. 3)Cancer relapse or disease progression must be confirmed after androgen deprivation therapy. 4)Age over 20 years old 5)4) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 6)Major organ function must be conserved before registration. 7)Written informed consent must be obtained from patients.

Exclusion criteria

Exclusion criteria: 1)Patients who received cytotxic-chemotherapy prior to this trial. 2)Patients who received estrogen therapy prior to this trial. 3)Patients who received radiation therapy to primary cancer site within 3 monthsprior to this trial. 4)Patients who diagnosed pulmonary fibrosis or interstitial pneumonitis. 5)Patients who have a history of acute myocardial infarction within 6 months. 6)Severe cormobidity (DM, heart disease, liver dysfunction etc.)

Design outcomes

Primary

MeasureTime frame
Time to treatment failure

Countries

Japan

Contacts

Public ContactKosuke Takehara

Nagasaki University Graduate School of Biomedical Sciences Department of Nephro-Urology

takehara@nagasaki-u.ac.jp095-819-7340

Outcome results

None listed

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