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

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ClinicalTrials.gov Identifier: NCT01050504
Recruitment Status : Recruiting
First Posted : January 15, 2010
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Description
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Brief Summary:
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 or disease Intervention/treatment
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

Detailed Description:

PRIMARY OBJECTIVES:

I. Obtain tissue through tumor biopsies and/or surgical resection 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.


Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
Study Start Date : August 2009
Estimated Primary Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. DNA genomic sequencing [ Time Frame: Up to 6 years ]
  2. Gene expression profile using microarray assays [ Time Frame: Up to 6 years ]
  3. Mutation mapping using the OncoMap and other genotyping techniques [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction [ Time Frame: Up to 6 years ]
  2. Proteomic profile [ Time Frame: Up to 6 years ]

Biospecimen Retention:   Samples With DNA
Blood and tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study
  • Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be 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
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050504


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Robert B. Montgomery    206-598-0856    rbmontgo@uw.edu   
Principal Investigator: Robert B. Montgomery         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert Montgomery Fred Hutch/University of Washington Cancer Consortium
More Information
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01050504     History of Changes
Other Study ID Numbers: 6932
NCI-2014-01087 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6932p
6932 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Prostatic Neoplasms
Neoplasms, Second Primary
Kidney Neoplasms
Ureteral Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Kidney Diseases
Ureteral Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes