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Clinical Trials/NCT00967954
NCT00967954
Unknown
Not Applicable

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

Cancer Research UK1 site in 1 country120 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Cancer Research UK
Enrollment
120
Locations
1
Primary Endpoint
Identification of molecular and pathophysiological changes
Last Updated
12 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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