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

NCT ID: NCT01050504

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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OUTLINE:

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

Conditions

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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 Recurrent Bladder Carcinoma Recurrent Prostate Carcinoma Recurrent Renal Pelvis and Ureter Urothelial Carcinoma Stage IV Bladder Cancer AJCC v7 Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage IV Prostate Cancer AJCC v7

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cytology Specimen Collection Procedure

Intervention Type OTHER

Correlative studies

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Cytology Specimen Collection Procedure

Correlative studies

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Cytologic Sampling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert B. Montgomery

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robert B. Montgomery

Role: CONTACT

206-598-0856

Facility Contacts

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Robert B. Montgomery

Role: primary

206-598-0856

Other Identifiers

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NCI-2014-01087

Identifier Type: REGISTRY

Identifier Source: secondary_id

6932p

Identifier Type: -

Identifier Source: secondary_id

6932

Identifier Type: OTHER

Identifier Source: secondary_id

RG1712006

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA097186

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6932

Identifier Type: -

Identifier Source: org_study_id

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