Prostate Cancer
Conditions
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Interventions
GENETICDNA analysis
GENETICRNA analysis
GENETICcomparative genomic hybridization
GENETICgene expression analysis
OTHERlaboratory biomarker analysis
PROCEDUREdiffusion-weighted magnetic resonance imaging
PROCEDUREmagnetic resonance spectroscopic imaging
Sponsors
Cancer Research UK
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * High clinical suspicion of prostate cancer, based on an abnormal digital rectal examination and PSA (\> 20 ng/mL) * Newly diagnosed, castration-resistant prostate cancer * Clinical stage ≥ T2c disease * Significant tumor volume on initial diagnostic biopsy (\> 50% of cores) * Likely to receive androgen deprivation therapy for prostate cancer PATIENT CHARACTERISTICS: * No contraindication to transrectal needle biopsy * No contraindication to MRI or prostate needle biopsy PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed