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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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