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

University of Washington

Status: Enrolling

Conditions: Metastatic Malignant Neoplasm in the Bone; Stage IV Prostate Cancer AJCC v7; Recurrent Renal Pelvis and Ureter Urothelial Carcinoma; Metastatic Malignant Neoplasm in the Soft Tissues; Recurrent Prostate Carcinoma; Recurrent Bladder Carcinoma; Stage IV Bladder Cancer AJCC v7; Metastatic Renal Pelvis and Ureter Urothelial Carcinoma; Malignant Solid Neoplasm; Localized Renal Pelvis and Ureter Urothelial Carcinoma; Stage IV Bladder Urothelial Carcinoma AJCC v7

Treatments: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01050504

RG1712006 (Other Identifier)

NCI-2014-01087 (Registry Identifier)

6932p

6932 (Other Identifier)

P50CA097186 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full description

OUTLINE:

Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Enrollment: 1,500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Ancillary-correlative (blood and tissue collection)

Description:

Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Treatment:

Other: Cytology Specimen Collection Procedure

Other: Laboratory Biomarker Analysis