A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Prostate Cancer is a common health issue facing men worldwide in most of the patients cancer will shrink with hormonal therapy. In some cases cancer returns or continues to grow despite very low levels of circulating male hormones, which is called Androgen-Independent Prostate Cancer (AIPC) or Hormone Refractory Prostate Cancer (HRPC). Mycobacterium w is known to share multiple antigen including PSA. It administration is associated with antigen specific generation of cell mediated immunity. Docetaxel is found to useful in management of metastatic hormone refractory prostate cancer, which is associated with improved survival, tumor progression free survival with reduction in pain, serum PSA and improvement in quality of life. Cyclophosphamide 300mg/sq.m will be used to eliminate T-regulatory cell responsible immuno suppression. The vaccine Mycobacterium w will be administered on a day following cyclophosphamide. For better initiation of immune responses Docetaxel will be given seven days following first dose of Mycobacterium w.

Official Title
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Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.

Conditions
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Hormone Refractory Prostate Cancer

Intervention / Treatment
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* Biological: Mycobacterium w.
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Docetaxel+Mw | Biological: Mycobacterium w.<br>* Immunomodulator<br>|
| Active Comparator: 1<br>Docetaxel | Drug: Docetaxel<br>* Chemotherapeutic agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Survival time |  | 12 months | 
| Time to Tumor Progression |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematological toxicity, PSA levels, Quality of Life |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRPC, Metastatic Hormone Refractory Prostate Cancer, Docetaxel, Mycobacterium w