Prostate CancerNCT00967889
Study of Tissue, Blood, and Urine Samples From Patients With Advanced Prostate Cancer
An observational study of Prostate Cancer, run by Cancer Research UK at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- gene expression analysis, protein analysis and biologic sample preservation procedure
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2002to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of advanced prostate cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Research UK at Cambridge Research Institute
Cambridge, England, CB2 0RE
David Neil, MD, 44-1223-763-365
About this study
Official title: Molecular Mechanisms of Disease Progression and the Development of Novel Treatment Strategies in Advanced Prostate Cancer (Northern Prostate Cancer Collaborative (ProMPT))
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- gene expression analysis, protein analysis, biologic sample preservation procedure, laboratory biomarker analysis
- Keywords
- stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
protein analysisGenetic
biologic sample preservation procedureOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJan 2002
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- David Neil, MD, Principal investigator, Cancer Research UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967889
- Sponsor's protocol ID
- CRUK-ProMPT
- Other IDs
- CDR0000638974, EU-20919
- Status last verified
- Aug 2009
- First submitted
- 27 Aug 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Disease Progression and the Development of Novel Treatment Strategies in Advanced Prostate Cancer (Northern Prostate Cancer Collaborative (ProMPT))
- ClinicalTrials.gov ID
- NCT00967889
- Acronym / sponsor ID
- CRUK-ProMPT
- Conditions
- Prostate Cancer
- Keywords
- stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jun 2011 (estimated)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| protein analysis | Genetic | – |
| biologic sample preservation procedure | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Neil, MD principal investigator
Cancer Research UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Cancer Research UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular pathology and mechanisms of disease progression. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.