A randomised phase II/III study of Docetaxel plus Prednisolone vs. Docetaxel plus Prednisolone plus Zoledronic acid vs. Docetaxel plus Prednisolone plus Strontium-89 vs. Docetaxel plus Prednisolone plus Zoledronic Acid plus Strontium-89 in Hormone Refractory Prostate Cancer metastatic to bone. - TRAPEZE: phase II/III efficacy and safety clinical trial in Hormone Refractory Prostate Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002295-41-GB

Enrollment

1240

Registered

2005-07-12

Start date

2009-01-29

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Hormone refractory Prostate Cancer (HRPC)

Interventions

Product Name: Taxotere Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel Concentration unit: mg/l milligram(s)/l

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Histologically / Cytologically proven prostate cancer or multiple sclerotic bone metastases with PSA>100ng/ml without histological confirmation. 2. Radiological evidence of bone metastasis 3. Documented disease progression 4. Life expectancy > 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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. Prior cytotoxic chemotherapy for HRPC, other than estramustine monotherapy 2. Known brain or Leptomeningal metastases 3. Symptomatic peripheral neuropathy > grade 2 (NCI CTC) 4. Any condition, which, in the opinion of the investigator, might interfere with the safety of the patient or evaluation of study objectives.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): 1. when the total number of patients entered into the study = 200 2. Toxicity accross the four treatment arms will be analysed in terms of incidence, severity, type, causality and duration. ; Main Objective: Phase II (stage of study) Feasiblity, tolerablity and safety in terms of cycles of docetaxel and zoledronic acid and strontium-89, cycle delays, dose reductions and toxicity. Phase III (Stage of study) Clinical Progression-free survival Cost and cost effectiveness of trial treatments ; Secondary Objective: Phase II (stage of study) Clinical progression-free survival Skeletal-related event free survival Pain progression-free survival Overall survival Costs Quality of LIfe Phase III (stage of study) Skeletal-related event-free survival Pain Progression-free survival Overall Survival Quality of Life Toxicity	—

Measure

Time frame

Primary end point(s): 1. when the total number of patients entered into the study = 200 2. Toxicity accross the four treatment arms will be analysed in terms of incidence, severity, type, causality and duration. ; Main Objective: Phase II (stage of study) Feasiblity, tolerablity and safety in terms of cycles of docetaxel and zoledronic acid and strontium-89, cycle delays, dose reductions and toxicity. Phase III (Stage of study) Clinical Progression-free survival Cost and cost effectiveness of trial treatments ; Secondary Objective: Phase II (stage of study) Clinical progression-free survival Skeletal-related event free survival Pain progression-free survival Overall survival Costs Quality of LIfe Phase III (stage of study) Skeletal-related event-free survival Pain Progression-free survival Overall Survival Quality of Life Toxicity

—

Countries

United Kingdom

Outcome results

None listed

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