Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.

Detailed Description
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OBJECTIVES: Primary To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel. In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere. Secondary To develop a predictive model based on the most accurate and sensitive combination of these biomarkers. OUTLINE: This is a multicenter study. Treatment Plan: All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule, dose and schedule at the discretion of the treating physician. Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks during study, and at disease progression or every 12 weeks after completion of study. Samples are analyzed for mRNA via RT-PCR.

Official Title
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Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer

Conditions
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Metastatic Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel
* Genetic: RNA analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: circulating tumor cell analysis
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must satisfy the following criteria: Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule. Patients must be aged 18 years or over. Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland. Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases). Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure. Patients must not have received prior treatment with chemotherapy. Patients must be able to give written informed consent. Prior radiotherapy is allowed. Concomitant use of bisphosphonates is allowed. Exclusion Criteria: Patients who have received previous cytotoxic therapy for prostate cancer are ineligible. Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial. History of other primary cancer, unless: Curatively resected non-melanomatous skin cancer Other primary solid tumour curatively treated with no known active disease present and no curative treatment for the last year.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Genetic: RNA analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: circulating tumor cell analysis|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of mRNA in circulating tumor cells as a predictor of response |  | ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of a predictive model |  | End of trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, bone metastases, liver metastases, lung metastases, hormone-resistant prostate cancer