Prostate Cancer Clinical Trial
Official title:
A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer
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.
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.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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