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

Recruiting

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

• Registration Number: NCT01050504
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (blood and tissue collection)	Laboratory Biomarker Analysis	Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
Ancillary-correlative (blood and tissue collection)	Cytology Specimen Collection Procedure	Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proteomic profile	Up to 6 years
Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction	Up to 6 years

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States