Study of Blood and Tissue Samples From Patients Receiving Androgen Deprivation for Newly Diagnosed Prostate Cancer
Recruitment status was Recruiting
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.
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
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer|
- Identification of molecular and pathophysiological changes [ Designated as safety issue: No ]
- Functional imaging as a non-invasive tool to measure treatment response [ Designated as safety issue: No ]
- Development of clinical models to predict tumor response [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|