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Molecular Correlates of Sensitivity and Resistance to Therapy in Prostate Cancer
This study is currently recruiting participants.
Verified September 2011 by Fred Hutchinson Cancer Research Center

First Received on September 30, 2009.   Last Updated on September 22, 2011   History of Changes
Sponsor: Fred Hutchinson Cancer Research Center
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01050504
  Purpose

This is a correlative tissue protocol to collect primary and metastatic prostate cancer specimens in order to discover new biomarkers, potential drug targets, study androgen axis signaling, and evaluate resistance developing in response to systemic therapy. Analysis of acquired specimens will provide the basis for the development of improved systemic therapy for prostate cancer patients. The mechanisms for conversion of treatment-sensitive to treatment-resistant prostate cancer are poorly understood. An improved understanding of the mechanisms of resistance to drugs targeting prostate cancer will allow design and testing of new therapeutic agents. With the advent of genomics and proteomics, which enable experiments to be conducted in parallel and on a large scale, one approach to identifying targets in cancer is to compare a statistically significant number of healthy tissues samples with cancerous tissue samples, and measure differences in DNA sequence patterns, gene expression patterns including microRNAs/noncoding RNA, patterns in protein levels or differences in metabolic products. Once individual or sets of differences have been established, the next challenge is to determine which differences are normal variations in pattern; which changes are causing the cancer cell to divide or survive in an unchecked manner; and which are repercussions of the causative change. Hypotheses for "lead targets" are arrived at through statistical analyses and validation experiments in both test tubes and in animal models of disease. These experiments are costly and intensive undertakings, but have generated an enormous amount of useful information and improved the investigators' collective understanding of how tumors develop, grow and survive.


Condition
Metastatic Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Molecular Correlates of Sensitivity and Resistance to Therapy in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Tissue from biopsies and blood collection will be used to study both sensitivity and resistance to prostate cancer treatment. [ Time Frame: Blood samples and biopsies are obtained on Day 1 of the study. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, tissue from metastatic disease.


Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Molecular correlates
Local (prostate or prostate bed) recurrent castration-resistant prostate cancer (CRPC) or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

>/=18 years of age, local (prostate or prostate bed) recurrent CRPC or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications, Platelet count >50,000; WBC >1,500, Hgb >8.0, INR<1.5; PTT<45

One of the following:

Metastatic castration sensitive prostate cancer Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml

and one of the following:

PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.

Evaluable disease progression by modified RECIST

Progression of metastatic bone disease on bone scan with > 2 new lesions

Criteria

Inclusion Criteria:

  • 18 years of age or older and ability to adequately understand and give informed consent
  • Local (prostate or prostate bed) recurrent CRPC or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications
  • Platelet count >50,000; WBC >2,000, Hgb >8.0, INR<1.5; PTT<45
  • No history of excessive unexplained bleeding from previous surgery
  • One of the following:

    • Metastatic castration sensitive prostate cancer or;
    • Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following:
    • PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart. Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)
    • Progression of metastatic bone disease on bone scan with > 2 new lesions

Exclusion Criteria:

  • Patients unable to stop chronic anticoagulation with warfarin or lovenox for less than 3 days
  • Serious or uncontrolled infection
  • Treatment with a VEGF inhibitor (such as Avastin) within the past 28 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050504

Contacts
Contact: Bruce Montgomery, MD 206 598-6158 rbmontgo@u.washington.edu
Contact: Branda Levchak 206-598-0851 brandal@uw.edu

Locations
United States, Washington
UWashington Recruiting
Seattle, Washington, United States, 98195
Contact: Branda Levchak     206-598-0851     brandal@uw.edu    
Sub-Investigator: Chew Felix, MD            
Sub-Investigator: Wendy Cohen, MD            
Sub-Investigator: William Ellis, MD            
Sub-Investigator: Manjiri Dighe, MD            
Sub-Investigator: Celestia Higane, MD            
Sub-Investigator: Evan Yu, MD            
Sub-Investigator: Elahe Mostaghel, MD            
Sub-Investigator: Peter Nelson, MD            
Sub-Investigator: Paul Lange, MD            
Sub-Investigator: Daniel Lin, MD            
Sub-Investigator: Kenneth Russell, MD            
Sub-Investigator: Lawrence True, MD            
Sub-Investigator: Robert Vessella, PhD            
Sub-Investigator: Muneesh Tewari, MD, PhD            
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Bruce Montgomery, MD     206-598-0860     rbmontgo@u.washington.edu    
Contact: Branda Levchak     206-598-0851     brandal@uw.edu    
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Bruce Montgomery, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: R. Bruce Montgomery, MD, Associate Professor, University of Washington, University of Washington
ClinicalTrials.gov Identifier: NCT01050504     History of Changes
Other Study ID Numbers: UW6932
Study First Received: September 30, 2009
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Prostate cancer
Metastatic
Sensitivity
Resistance

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 February 09, 2012