Collecting blood and tissue samples from patients with recurrent or metastatic prostate or bladder cancer
Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
This study is collecting blood and tissue samples from patients with recurrent or advanced prostate or bladder cancer to see if they can find new ways to improve treatment and understand why some treatments don’t work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT01050504 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on collecting and analyzing blood and tissue samples from patients diagnosed with locally recurrent or metastatic prostate or bladder/urothelial cancer. The samples will be studied in the laboratory to identify new biomarkers, potential drug targets, and understand treatment resistance. Patients will undergo procedures for sample collection, including mutation mapping, DNA sequencing, and gene expression profiling. The goal is to enhance the understanding of these cancers and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include patients with localized or metastatic bladder/urothelial or prostate cancer who have accessible biopsy sites.
Not a fit: Patients with cancers that are not accessible for biopsy or those without a diagnosis of prostate or bladder cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new treatment options and improved outcomes for patients with recurrent or metastatic prostate and bladder cancer.
How similar studies have performed: Other studies have shown success in using similar approaches to identify biomarkers and improve treatment strategies in cancer research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Robert B. Montgomery — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Robert B. Montgomery
- Email: rbmontgo@uw.edu
- Phone: 206-598-0856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.