Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Studying samples of blood and tissue 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 research study is looking at blood and tissue samples from patients with prostate cancer receiving androgen deprivation therapy.

Detailed Description
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OBJECTIVES: To identify the molecular and pathophysiological changes which occur during the early stages of androgen deprivation (AD) and during emerging castration-resistant prostate cancer. To test functional imaging as a non-invasive tool to measure treatment response and validate this using biological endpoints. To develop clinical models to predict how tumors will respond to AD and identify new targets once AD fails. OUTLINE: Group A: Patients likely to receive androgen deprivation (AD) as first-line therapy undergo blood and prostate biopsy sample collection before and after treatment on days 0 and 14 or 90. Patients receive an androgen receptor inhibitor followed by maintenance with a gonadotropin-releasing hormone analogue beginning on day 0. Patients also undergo diffusion-weighted MRI, MR spectroscopic imagining, quantitative T1W mapping, and T1W perfusion sequence. Group B: Patients already receiving AD undergo blood and prostate biopsy sample collection within 4 weeks of diagnosis of castration-resistant prostate cancer and before initiating any second-line therapy. Blood and tissue samples are assessed via DNA and RNA genetic analysis, gene expression studies, and comparative genomic hybridization to identify novel markers of androgen response and resistance. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Official Title
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A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: antiandrogen therapy
* Drug: releasing hormone agonist therapy
* Genetic: DNA analysis
* Genetic: RNA analysis
* Genetic: comparative genomic hybridization
* Genetic: gene expression analysis
* Other: laboratory biomarker analysis
* Procedure: diffusion-weighted magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: High clinical suspicion of prostate cancer, based on an abnormal digital rectal examination and PSA (> 20 ng/mL) Newly diagnosed, castration-resistant prostate cancer Clinical stage ≥ T2c disease Significant tumor volume on initial diagnostic biopsy (> 50% of cores) Likely to receive androgen deprivation therapy for prostate cancer PATIENT CHARACTERISTICS: No contraindication to transrectal needle biopsy No contraindication to MRI or prostate needle biopsy PRIOR CONCURRENT THERAPY: See Disease Characteristics
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: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antiandrogen therapy|nan|
|Drug: releasing hormone agonist therapy|nan|
|Genetic: DNA analysis|nan|
|Genetic: RNA analysis|nan|
|Genetic: comparative genomic hybridization|nan|
|Genetic: gene expression analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: diffusion-weighted magnetic resonance imaging|nan|
|Procedure: magnetic resonance spectroscopic imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of molecular and pathophysiological changes |  |  | 
| Functional imaging as a non-invasive tool to measure treatment response |  |  | 
| Development of clinical models to predict tumor response |  |  | 

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