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

September 30, 2009
May 23, 2014
August 2009
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT01050504 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate Cancer
Molecular Correlates of Sensitivity and Resistance to Therapy in Prostate Cancer

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, soft tissue or bone metasteses

Non-Probability Sample

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

  • 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
    Correlative studies
  • Other: cytology specimen collection procedure
    Correlative studies
    Other Name: cytologic sampling
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.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: cytology specimen collection procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
August 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
United States
 
NCT01050504
6932, NCI-2014-01087, 6932, P30CA015704
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Robert Montgomery Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP