Clinical trial · Interventional
Trial of Docetaxel-samarium in Patients With Hormone-refractory Advanced Prostate Cancer
A Prospective Phase II Trial of Docetaxel-samarium in Patients With Hormone-refractory Advanced Prostate Cancer Who Achieve a Response or a Stabilization to Docetaxel-estramustine
NCT00126230CI-TRIAL-00122662terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel and samarium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to progression
Secondary outcomes (3)
- measure
- Prostate specific antigen (PSA) response rate
- measure
- Toxicity
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years and less than 80 years * Histologically-proven adenocarcinoma of the prostate * Evidence of bone metastases and progressive, hormone-refractory, disease * No previous chemotherapy * No previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion * No previous carcinoma, except basal-cell carcinoma of the skin * Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min * Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value * Signed informed consent. Exclusion Criteria: * Patients infected by the Human Immunodeficiency Virus (HIV) * Patients who do not fit inclusion criteria
References
Publications (1)
- RESULTFizazi K, Beuzeboc P, Lumbroso J, Haddad V, Massard C, Gross-Goupil M, Di Palma M, Escudier B, Theodore C, Loriot Y, Tournay E, Bouzy J, Laplanche A. Phase II trial of consolidation docetaxel and samarium-153 in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol. 2009 May 20;27(15):2429-35. doi: 10.1200/JCO.2008.18.9811. Epub 2009 Apr 13. PMID 19364971