Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT01050504

Conditions

Localized Renal Pelvis and Ureter Urothelial Carcinoma

Malignant Solid Neoplasm

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Neoplasm in the Soft Tissues

Metastatic Renal Pelvis and Ureter Urothelial Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cytology Specimen Collection Procedure

Laboratory Biomarker Analysis

Study Details

Brief summary:

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.

Conditions

Localized Renal Pelvis and Ureter Urothelial Carcinoma

Malignant Solid Neoplasm

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Neoplasm in the Soft Tissues

Metastatic Renal Pelvis and Ureter Urothelial Carcinoma

Study ID

NCT01050504

Start date

Aug, 2009

Status verified date

Aug, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-correlative (blood and tissue collection)

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

Interventions

Cytology Specimen Collection Procedure

Correlative studies

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • DNA genomic sequencing [ Time Frame: Up to 6 years ]
  • Gene expression profile using microarray assays [ Time Frame: Up to 6 years ]
  • Mutation mapping using the OncoMap and other genotyping techniques [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Robert B. Montgomery

206-598-0856rbmontgo@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Robert B. Montgomery

206-598-0856rbmontgo@uw.edu

Principal Investigator:

Robert B. Montgomery

More Information

Sponsor

University of Washington

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-06.