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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967954
First Posted: August 28, 2009
Last Update Posted: January 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Prostate Cancer 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Study of Changes in the Prostate Following Androgen Deprivation to Investigate Therapy Response and Resistance in Clinical Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: September 2008
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967954


Locations
United Kingdom
Cancer Research UK at Cambridge Research Institute Recruiting
Cambridge, England, United Kingdom, CB2 0RE
Contact: Vincent Gnanapragasam, MD    44-1223-348-363      
Sponsors and Collaborators
Cancer Research UK
Investigators
Principal Investigator: Vincent Gnanapragasam, MD Cancer Research UK
  More Information

ClinicalTrials.gov Identifier: NCT00967954     History of Changes
Other Study ID Numbers: CDR0000639017
CRUK-CHIRRP
EU-20920
First Submitted: August 27, 2009
First Posted: August 28, 2009
Last Update Posted: January 10, 2014
Last Verified: August 2009

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Androgens
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists