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

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT01050504

Collaborator

National Cancer Institute (NCI) (NIH)

1,500

Enrollment

Location

181

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study 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	Phase
Localized Renal Pelvis and Ureter Urothelial Carcinoma Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Soft Tissues Metastatic Renal Pelvis and Ureter Urothelial Carcinoma Recurrent Bladder Carcinoma Recurrent Prostate Carcinoma Recurrent Renal Pelvis and Ureter Urothelial Carcinoma Stage IV Bladder Cancer AJCC v7 Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage IV Prostate Cancer AJCC v7	Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis

Detailed Description

OUTLINE:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	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 Names: Cytologic Sampling Other: Laboratory Biomarker Analysis Correlative studies

Arm

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 Names:

Cytologic Sampling

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

DNA genomic sequencing [Up to 6 years]
Gene expression profile using microarray assays [Up to 6 years]
Mutation mapping using the OncoMap and other genotyping techniques [Up to 6 years]

Secondary Outcome Measures

Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction [Up to 6 years]
Proteomic profile [Up to 6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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