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

Launched by UNIVERSITY OF WASHINGTON · Jan 14, 2010

Keywords

ClinConnect Summary

This clinical trial is focused on collecting and studying blood and tissue samples from patients who have prostate or bladder/urothelial cancer that has come back or spread to other parts of the body. By analyzing these samples, researchers hope to discover new ways to understand the cancer, identify potential targets for new treatments, and learn why some treatments may not be working as well as hoped. This research could ultimately lead to improved treatment options for patients facing these types of cancers.

To participate in the trial, individuals must be men or women diagnosed with localized or metastatic bladder/urothelial or prostate cancer, and their disease should be accessible for biopsy. Participants need to be able to understand and sign consent forms and meet certain health criteria, such as having a safe level of blood cells. Those who do not have cancer may also be included if they are undergoing certain procedures. If you choose to take part, you can expect to provide blood and possibly tissue samples, which will help contribute to important cancer research.

Gender

MALE

Eligibility 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