Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood and urine 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 and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.

Detailed Description
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OBJECTIVES: Detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy. Identify prognostic and biochemical markers of early disease progression in patients treated with this regimen. Identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity. Identify molecular signatures that allow identification of targets for therapeutic intervention. OUTLINE: This is a multicenter study. Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy (per standard treatment). Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.NOTE: * Patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial. Blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis. After completion of study therapy, patients are followed up periodically for 5 years and yearly thereafter for the duration of the trial.

Official Title
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Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Non-interventional
* Genetic: Protein expression analysis
* Genetic: Proteomic profiling
* Other: Laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18 years or over. Histologically confirmed invasive adenocarcinoma of the prostate (by TURP or TRUS). Localised prostate cancer with a Gleason score 7 Short term hormonal treatment 4-8 months Performance status of KPS ≥ 60 / WHO 0-2 Absence of distant metastases Exclusion criteria: The patient has previously received treatment for prostate cancer other than TURP/ TRUS The patient has had a bilateral orchidectomy The patient has previously received hormonal treatment for prostate cancer Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. In the opinion of the investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease The patient has or had other co-existing malignancies within the past 5 years other than non- melanoma skin cancer Treatment with non-approved or investigational drug within 30 days before day one of the trial

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 |
| --- |
|Other: Non-interventional|Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy per standard treatment. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.|
|Genetic: Protein expression analysis|nan|
|Genetic: Proteomic profiling|nan|
|Other: Laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum and urine proteomic profiles |  | Ongoing until patient progression | 
| Prognostic and biochemical markers of early disease progression |  | Ongoing until patient progression | 
| Protein expression and temporal alterations |  | Ongoing until patient progression | 
| Molecular targets |  | Ongoing until patient progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer