Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
5 other identifiers
observational
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
January 15, 2026
January 1, 2026
19.5 years
September 30, 2009
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction
Up to 6 years
Proteomic profile
Up to 6 years
Study Arms (1)
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.
Interventions
Correlative studies
Correlative studies
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Biospecimen
Blood and tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert B. Montgomery
Fred Hutch/University of Washington Cancer Consortium
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2009
First Posted
January 15, 2010
Study Start
August 1, 2009
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share