Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
NCT ID: NCT00967954
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2008-09-30
Brief Summary
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PURPOSE: This research study is looking at blood and tissue samples from patients with prostate cancer receiving androgen deprivation therapy.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
Interventions
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antiandrogen therapy
releasing hormone agonist therapy
DNA analysis
RNA analysis
comparative genomic hybridization
gene expression analysis
laboratory biomarker analysis
diffusion-weighted magnetic resonance imaging
magnetic resonance spectroscopic imaging
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Vincent Gnanapragasam, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Research UK
Locations
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Cancer Research UK at Cambridge Research Institute
Cambridge, England, United Kingdom
Countries
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Facility Contacts
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Vincent Gnanapragasam, MD
Role: primary
Other Identifiers
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CRUK-CHIRRP
Identifier Type: -
Identifier Source: secondary_id
EU-20920
Identifier Type: -
Identifier Source: secondary_id
CDR0000639017
Identifier Type: -
Identifier Source: org_study_id
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