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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00525408

Acronym

HRPC

Enrollment

134

Registered

2007-09-05

Start date

2007-11-30

Completion date

2013-01-31

Last updated

2012-03-12

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

Conditions

Hormone Refractory Prostate Cancer

Keywords

HRPC, Metastatic Hormone Refractory Prostate Cancer, Docetaxel, Mycobacterium w

Brief summary

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

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.

Interventions

BIOLOGICALMycobacterium w.

Immunomodulator

DRUGDocetaxel

Chemotherapeutic agent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Median Survival time	12 months
Time to Tumor Progression	12 Months

Secondary

Measure	Time frame
hematological toxicity, PSA levels, Quality of Life	12 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026