Clinical trial · Interventional
Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer
Randomized Phase Ii Trial Of Weekly Docetaxel, Estramustine And Prednisone Versus Docetaxel And Prednisone In Patient With Hormone-Resistant Prostate Cancer
NCT00541281CI-TRIAL-00002734completedPhase 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)
we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Resistant Prostate Cancer | — | UNRESOLVED | — |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| estramustine | Drug | Estramustine | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- weekly docetaxel and prednisone
- interventionNames
- Drug: docetaxel
- Drug: estramustine
- Drug: prednisone
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- weekly docetaxel (35mg/m\&) plus prednisone 10mg a day associated with estramustine form day 1to 5 and 8 to 12
- interventionNames
- Drug: docetaxel
- Drug: prednisone
Primary outcomes (1)
- measure
- To compare the efficacy of the association of Docetaxel and Estramustineand Prednisone versus Docetaxel and Prednisone in the treatment of hormone refractory prostate cancer in terms o PSA response
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent prior to beginning protocol specific procedures. * 18 years * Histologically/cytologically proven prostate adenocarcinoma. * Documented metastatic prostate adenocarcinoma * Patients must have received prior hormonal therapy as defined below: * Castration by orchiectomy and/or LHRH agonists with or without * Antiandrogens * Other hormonal agents (e.g., ketoconazole, ...) * Testosterone level should be \< 50 ng/dl in all patients (castrated level). * Respect of antiandrogen withdrawal period * No prior chemotherapy regimen at the exception of estramustine phosphate. * documented disease progression defined either (i) by PSA increase and/or (ii) imaging: * Prior radiation therapy (to less or equal than 25% of the bone marrow only) is allowed. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects. * Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery. * Life expectancy \> 3 months. * ECOG performance status 0-2. * Normal cardiac function. Exclusion Criteria: * Prior chemotherapy except estramustine phosphate.(2) * Prior isotope therapy * Prior radiotherapy to \>25% of bone marrow * Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for \>5 years. * Known brain or leptomeningeal involvement. * Symptomatic peripheral neuropathy \> grade 2 * Other serious illness or medical condition * Concurrent treatment with other experimental drugs. * Treatment with any other anti-cancer therapy (except LHRH agonists) * Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to the administration of docetaxel.
References
Publications (0)
Data not yet available
No reference posted for this study.