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
  Purpose

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.


Condition Intervention
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
Other: Laboratory Biomarker Analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood and tissue


Estimated Enrollment: 300
Study Start Date: August 2009
Estimated Primary Completion Date: August 2015 (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, and gene profiling.
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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, 6932p, 6932, P30CA015704
Study First Received: September 30, 2009
Last Updated: May 21, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Kidney Neoplasms
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Ureteral Neoplasms
Urinary Bladder Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Ureteral Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on September 03, 2015