Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01050504
First received: September 30, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

This research trial collects and studies tissue and blood samples from patients with prostate cancer that is locally recurrent or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat prostate cancer.


Condition Intervention
Bone Metastases
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Soft Tissue Metastases
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Other: laboratory biomarker analysis
Other: cytology specimen collection procedure

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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Mutation mapping using the OncoMap and other genotyping techniques [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • DNA genomic sequencing [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Gene expression profile using microarray assays [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Proteomic profile [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • mRNA expression profile in plasma and tissue [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, soft tissue or bone metasteses


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-correlative (blood and tissue collection)
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, RNA analysis, and gene profiling.
Other: laboratory biomarker analysis
Correlative studies
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

Detailed Description:

PRIMARY OBJECTIVE:

I. Obtain tumor biopsies and matched blood samples from patients with localized and metastatic castration sensitive or castration resistant prostate cancer for: mutation mapping using OncoMap and other high throughput genotyping technologies; sequencing of tumor genomic deoxyribonucleic acid (DNA); global assessment of gene expression to generate hypotheses that can be tested in subsequent trials (by gene expression microarrays and/or complementary [c]DNA sequencing and/or micro-ribonucleic acid [RNA]/noncoding RNA analysis); profiling of genes involved in androgen metabolism; quantitating peptides, hormones and other locally-derived or systemic metabolites present in tumor tissues.

SECONDARY OBJECTIVES:

I. Determine whether levels of other androgen synthetic enzymes predict responses to agents targeting the androgen-AR signaling axis.

II. Determine whether intratumoral androgen levels are increased compared to serum levels, and whether they correlate with androgen synthetic enzyme levels and/or responses to therapy.

III. Determine whether time to progression on therapy correlates with androgen biosynthetic enzymes or hormone levels.

IV. Determine whether gene expression profiling can predict response and time to progression for chemotherapy or targeted agents.

V. Compare plasma expression profiles of microRNAs/noncoding RNAs to those of prostate cancer tissue and determine whether plasma microRNA/noncoding RNA signatures can predict response and time to progression for hormonal therapies, chemotherapy, and/or targeted agents.

OUTLINE:

Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, RNA analysis, and gene profiling.

  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

Patients with prostate cancer treated in genitourinary oncology practices at University of Washington Medical Center, Seattle Cancer care Alliance and Harborview Medical Center

Criteria

Inclusion Criteria:

  • Ability to adequately understand and give informed consent
  • 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
  • Platelet count > 50,000
  • White blood cell (WBC) > 1,500
  • Hemoglobin (Hgb) > 8.0
  • International normalized ratio (INR) < 1.5
  • Partial thromboplastin time (PTT) < 45
  • No history of excessive unexplained bleeding from previous surgery

Exclusion Criteria:

  • Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days
  • Serious or uncontrolled infection
  • Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days
  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: NCT01050504

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Robert B. Montgomery    206-598-0856      
Principal Investigator: Robert B. Montgomery         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Robert Montgomery Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01050504     History of Changes
Other Study ID Numbers: 6932, NCI-2014-01087, 6932, P30CA015704
Study First Received: September 30, 2009
Last Updated: May 23, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014