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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 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 21, 2015
Last verified: May 2015

September 30, 2009
May 21, 2015
August 2009
August 2015   (final data collection date for primary outcome measure)
  • DNA genomic sequencing [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Gene expression profile using microarray assays [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Mutation mapping using the OncoMap and other genotyping techniques [ Time Frame: Up to 6 years ] [ 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: Up to 6 years ] [ Designated as safety issue: No ]
  • Proteomic profile [ Time Frame: Up to 6 years ] [ 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 or Bladder/Urothelial Cancer
Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

This research trial collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial 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 the cancer.

PRIMARY OBJECTIVES:

I. Obtain tumor biopsies and matched blood samples from patients with localized and metastatic prostate and bladder/urothelial 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; profiling of genes involved in androgen metabolism and DNA repair; quantitating peptides, hormones and other locally-derived or systemic metabolites present in tumor tissues.

II. Obtain samples from controls, including blood or tissue for comparison with samples noted above.

SECONDARY OBJECTIVES:

I. Determine whether levels of other androgen synthetic enzymes predict responses to agents targeting the androgen-androgen receptor (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. Identify immune B and/or T cell markers, sequencing and/or antibodies that may correlate with response, time to progression and/or overall survival for patients undergoing immunotherapy.

OUTLINE:

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

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

Blood and tissue

Non-Probability Sample

Patients with prostate or bladder/urothelial cancer treated in genitourinary oncology practices at University of Washington Medical Center, Seattle Cancer care Alliance and Harborview Medical Center and healthy controls

  • Healthy Control
  • Localized Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Neoplasm in the Soft Tissues
  • Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Recurrent Bladder Carcinoma
  • Recurrent Prostate Carcinoma
  • Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Stage IV Bladder Cancer
  • Stage IV Bladder Urothelial Carcinoma
  • Stage IV Prostate Cancer
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Ancillary-correlative (blood and tissue collection)
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
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 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
  • Ability to adequately understand and give informed consent
  • Local 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
Yes
United States
 
NCT01050504
6932, NCI-2014-01087, 6932p, 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 2015

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