Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
Recruiting · NCT01050504 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
Cytology Specimen Collection ProcedureLaboratory Biomarker Analysis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Fred Hutch/University of Washington Cancer Consortium - Seattle, Washington, United States