Study of Tissue, Blood, and Urine Samples From Patients With Advanced 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:
NCT00967889
First received: August 27, 2009
Last updated: August 9, 2013
Last verified: August 2009
  Purpose

RATIONALE: Studying samples of tissue, blood, and urine 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 find better ways to treat the cancer.

PURPOSE: This research study is looking at tissue, blood, and urine samples from patients with advanced prostate cancer.


Condition Intervention
Prostate Cancer
Genetic: gene expression analysis
Genetic: protein analysis
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Molecular Mechanisms of Disease Progression and the Development of Novel Treatment Strategies in Advanced Prostate Cancer (Northern Prostate Cancer Collaborative (ProMPT))

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Molecular pathology and mechanisms of disease progression [ Designated as safety issue: No ]
  • Development of novel treatment strategies for patients with advanced prostate cancer [ Designated as safety issue: No ]
  • Evaluation of novel markers and treatment and epidemiological approaches [ Designated as safety issue: No ]

Study Start Date: January 2002
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To study molecular pathology and mechanisms of disease progression.
  • To develop novel treatment strategies for patients with advanced prostate cancer.
  • To evaluate novel markers and treatment and epidemiological approaches.

OUTLINE: This is a multicenter study.

  • Program I (Molecular Signaling in Advanced Prostate Cancer): Researchers from Newcastle, York, and Bristol analyze androgen receptor (AR) (i.e., AR regulated genes and AR co-activators and co-repressors) and fibroblast growth factor (FGF) signaling and examine the cross-talk between these two systems and the insulin-like growth factor (IGF) axis.
  • Program II (Mechanisms of Skeletal Metastases): Researchers from Newcastle, Sheffield, Bristol, and Manchester analyze mechanisms of skeletal metastases and candidate factors responsible for skeletal metastases (e.g., BMP-6, TGF-β1, IL-6, and IL-6 receptor). The balance between proteases and their inhibitors is also analyzed.
  • Program III (Prostate Targeting, Models, and Novel Approaches to Therapy): Researchers from Newcastle, Sheffield, York, and Manchester analyze and develop reagents and methods that will facilitate novel gene-based approaches to therapy, including prostate tissue specific gene expression, model systems of gene function and therapeutic studies, translational gene-based therapies, and effectors for potential gene therapy.
  • Program IV (Developmental Therapeutics): Researchers from Newcastle, York, and Manchester analyze novel proteins identified during the study to synthesize novel reagents aimed at disrupting pathways and signaling molecules that have been shown to be of critical importance to prostate cancer (e.g., AR and FGF signaling).
  • Program V (Biorepository and Database): Tissue, DNA, blood, serum, and urine samples from Newcastle, Sheffield, and Manchester biorepositories are stored and used for analysis in programs I-IV. Support for tissue and data collection as well as database management is provided to enable these resources to be made available to the wider research community.
  • Program VI (Clinical Trials and Health Services Research): Researchers from Newcastle, Sheffield, Manchester, and Bristol participate in phase I trials using dendritic cells and gene-directed enzyme prodrug therapy (GDEPT) approaches to analyze environmental interactions with the genotype and evaluate prevention strategies (e.g., diet) that may underlie variations in the incidence of prostate cancer.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of advanced prostate cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967889

Locations
United Kingdom
Cancer Research UK at Cambridge Research Institute Recruiting
Cambridge, England, United Kingdom, CB2 0RE
Contact: David Neil, MD    44-1223-763-365      
Sponsors and Collaborators
Cancer Research UK at Cambridge Research Institute
Investigators
Principal Investigator: David Neil, MD Cancer Research UK at Cambridge Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00967889     History of Changes
Other Study ID Numbers: CRUK-ProMPT, CDR0000638974, EU-20919
Study First Received: August 27, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014