Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00967954|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 28, 2009
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||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||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Official Title:||A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||August 2013|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967954
|Cancer Research UK at Cambridge Research Institute||Recruiting|
|Cambridge, England, United Kingdom, CB2 0RE|
|Contact: Vincent Gnanapragasam, MD 44-1223-348-363|
|Principal Investigator:||Vincent Gnanapragasam, MD||Cancer Research UK|