NCT00967954

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-08-01
• First posted: 2009-08-28
• Last updated: 2014-01-10

Locations

1 site across 1 country: United Kingdom