Hormone-refractory Prostate cancer first Line Intermittent Taxotere and Estramustine. - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005728-17-IT

Enrollment

128

Registered

2007-01-16

Start date

2006-11-02

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer. MedDRA version: 6.1 Level: PT Classification code 10036909

Interventions

Trade Name: TAXOTERE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Docetaxel Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1 histologically proven diagnosis of prostate cancer 2 previous therapy with LHRH-analogue 3 PSA value rise during second line hormonal manipulation 4 performance status less than ECOG 2 5 life expectancy more than 12 weeks 6 adequate bone marrow function 7 written consent informed 8 patients ability to fill the quality of life questionnaire Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1 disease progression without PSA rise 2 active infection 3 previous chemotherapy for prostate cancer 4 non adequate liver or renal functions 5 major diseases limiting chemotherapy 6 major cardiovascular diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: 1 evaluation of impact on patients quality of life of intermittent schedule 2 evaluation of efficacy of estramustine docetaxel association in terms of disease control;Secondary Objective: 1 evaluation of treatment tolerability 2 evaluation of quality of life parameters in relation to the treatments 3 evaluation of treatments activity in terms of disease burden 4 evaluation of treatments activity in terms of biochemical response 5 evaluation of overal survival and progression free survival 6 evaluation of duration of both biochemical response and clinical response 7 evaluation of treatments impact on pain;Primary end point(s): 1 percentual changes of GHS scale of EORTC QLQ-30 between relevations at randomization and after 12 months 2 absence of biochemical progression at 12 months after randomization	—

Measure

Time frame

Main Objective: 1 evaluation of impact on patients quality of life of intermittent schedule 2 evaluation of efficacy of estramustine docetaxel association in terms of disease control;Secondary Objective: 1 evaluation of treatment tolerability 2 evaluation of quality of life parameters in relation to the treatments 3 evaluation of treatments activity in terms of disease burden 4 evaluation of treatments activity in terms of biochemical response 5 evaluation of overal survival and progression free survival 6 evaluation of duration of both biochemical response and clinical response 7 evaluation of treatments impact on pain;Primary end point(s): 1 percentual changes of GHS scale of EORTC QLQ-30 between relevations at randomization and after 12 months 2 absence of biochemical progression at 12 months after randomization

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026