Actively Recruiting

Age: 18Years +
MALE
Healthy Volunteers
ID01050504

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Led by University of Washington · Updated on 2026-01-15

1500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are collecting and studying blood and tissue samples from patients with prostate or bladder/urothelial cancer that has returned near the original tumor or spread to other parts of the body. The study aims to learn more about new biomarkers, drug targets, and resistance to treatments to help improve future cancer care. This observational study is sponsored by the University of Washington and focuses on molecular changes in genitourinary cancers. Participants provide blood and tissue samples that will be analyzed using mutation mapping, DNA sequencing, gene expression microarrays, and gene profiling techniques. The study involves correlative procedures such as cytology specimen collection and laboratory biomarker analysis. Samples may also come from surgical procedures or archival tissue donations. Men and women without cancer may also provide samples if collected during non-research procedures. During the study, researchers will measure DNA sequencing, gene expression profiles, and mutation mapping for up to six years. Additional assessments include examining androgen metabolic enzymes and proteomic profiles. Participants may have tissue biopsies from accessible tumor sites or blood samples taken. The study monitors safety by requiring certain blood counts and coagulation levels. Participation may last several years depending on the follow-up and sample collection schedule.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases, or soft tissue metastases
  • Men and women without cancer may participate if blood or normal tissue is collected during non-research procedures
  • Ability to understand and give informed consent
  • Disease at sites accessible to biopsy with minimal risk or ability to obtain tissue from surgical procedures or archival tissue donation
  • Platelet count greater than 50,000
  • White blood cell count greater than 1,500
  • Hemoglobin greater than 8.0
  • International normalized ratio less than 1.5
  • Partial thromboplastin time less than 45
  • No history of excessive unexplained bleeding from previous surgery
Not Eligible

You will not qualify if you...

  • 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 within the past 28 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 6 years

Participants provide blood and tissue samples for analysis including mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Visits as needed for sample collection during routine care and research procedures

Trial Site Locations

Total: 1 location

1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

R

Robert B. Montgomery

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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