Clinical trial · Interventional
A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
NCT00525408CI-TRIAL-00006452HRPCterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim Analysis report indicates trial futility
Summary
Brief summary (as posted)
This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.
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 |
|---|---|---|---|
| Hormone Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Mycobacterium w. | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2
- description
- Docetaxel+Mw
- interventionNames
- Biological: Mycobacterium w.
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Docetaxel
- interventionNames
- Drug: Docetaxel
Primary outcomes (2)
- measure
- Median Survival time
- timeFrame
- 12 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease. * Disease progression during antiandrogen therapy, having surgical or medical castration status. * Karnofsky Performance Status 50-100 * Normal cardiac function * Life expectancy at least 24 weeks. * Laboratory criteria for eligibility will include * A neutrophil count of at least 1500 per cubic millimeter * A hemoglobin level of at least 9 gm% * A platelet count of at least 1000,000 per cubic millimeter. * A total bilirubin not grater than 1.5 times the upper limit of the normal range for each institution. * Serum creatinine levels not more than 1.5 times the upper limit of the normal range * Written informed consent Exclusion Criteria: * Prior treatment with cytotoxic agents or radioisotopes * Estrogen use for at least three months * History of another cancer within the preceding five years (except basal or squamous-cell skin cancer) * Brain or leptomeningeal metastases * Symptomatic peripheral neuropathy of grade 2 or higher * Uncontrolled intercurrent illness that would limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.