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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00967954
First received: August 27, 2009
Last updated: January 9, 2014
Last verified: August 2009
  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 [ Designated as safety issue: No ]
  • Functional imaging as a non-invasive tool to measure treatment response [ Designated as safety issue: No ]
  • Development of clinical models to predict tumor response [ Designated as safety issue: No ]

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

Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 at Cambridge Research Institute
Investigators
Principal Investigator: Vincent Gnanapragasam, MD Cancer Research UK at Cambridge Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00967954     History of Changes
Other Study ID Numbers: CDR0000639017, CRUK-CHIRRP, EU-20920
Study First Received: August 27, 2009
Last Updated: January 9, 2014
Health Authority: Unspecified

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
Androgens
Androgen Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormone Antagonists

ClinicalTrials.gov processed this record on September 22, 2014