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

Cancer Research UK (CRUK)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: magnetic resonance spectroscopic imaging; Drug: releasing hormone agonist therapy; Genetic: RNA analysis; Genetic: DNA analysis; Procedure: diffusion-weighted magnetic resonance imaging; Genetic: comparative genomic hybridization; Drug: antiandrogen therapy; Other: laboratory biomarker analysis; Genetic: gene expression analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00967954

CRUK-CHIRRP

EU-20920

CDR0000639017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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