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

Complete title: Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Research Study Number       6932
    
Principal Investigator       Robert Montgomery, MD
    
Phase       NA

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Research Study Description

This research trial 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Male

Study Population

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

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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

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

Other exclusion criteria may apply.



Research Study Number       6932
    
Contact       Robert Montgomery, MD
    
Telephone       206/598-0860
    
E-mail      
    
   

Keywords
Bladder Cancer; Genitourinary Cancer; Hematologic Malignancies; Kidney Cancer; Prostate Cancer; Renal Cancer; Solid Tumors; Urethral Cancer; Urogenital Neoplasms; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Bone Marrow Diseases

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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