Study of Tissue, Blood, and Urine Samples From Patients With Advanced Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
gene expression analysis
protein analysis
biologic sample preservation procedure
laboratory biomarker analysis
Sponsored by
About this trial
This is an observational trial for Prostate Cancer focused on measuring stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of advanced prostate cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Sites / Locations
- Cancer Research UK at Cambridge Research InstituteRecruiting
Outcomes
Primary Outcome Measures
Molecular pathology and mechanisms of disease progression
Development of novel treatment strategies for patients with advanced prostate cancer
Evaluation of novel markers and treatment and epidemiological approaches
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967889
Brief Title
Study of Tissue, Blood, and Urine Samples From Patients With Advanced Prostate Cancer
Official Title
Molecular Mechanisms of Disease Progression and the Development of Novel Treatment Strategies in Advanced Prostate Cancer (Northern Prostate Cancer Collaborative (ProMPT))
Study Type
Observational
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research UK
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention Type
Other
Intervention Name(s)
biologic sample preservation procedure
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Molecular pathology and mechanisms of disease progression
Title
Development of novel treatment strategies for patients with advanced prostate cancer
Title
Evaluation of novel markers and treatment and epidemiological approaches
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of advanced prostate cancer
PATIENT CHARACTERISTICS:
Not specified
PRIOR CONCURRENT THERAPY:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Neil, MD
Organizational Affiliation
Cancer Research UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Research UK at Cambridge Research Institute
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Neil, MD
Phone
44-1223-763-365
12. IPD Sharing Statement
Learn more about this trial
Study of Tissue, Blood, and Urine Samples From Patients With Advanced Prostate Cancer
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