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

• ClinicalTrials.gov Identifier: NCT01050504
• Recruitment Status: Recruiting
• First Posted: January 15, 2010
• Last Update Posted: January 25, 2024
• Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Washington

Tracking Information

• First Submitted Date: September 30, 2009
• First Posted Date: January 15, 2010
• Last Update Posted Date: January 25, 2024
• Study Start Date: August 2009
• Estimated Primary Completion Date: January 31, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 21, 2015)

• 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 ]

• Original Primary Outcome Measures (submitted: January 14, 2010): Tissue from biopsies and blood collection will be used to study both sensitivity and resistance to prostate cancer treatment. [ Time Frame: Blood samples and biopsies are obtained on Day 1 of the study. ]

Current Secondary Outcome Measures (submitted: May 21, 2015)

• Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction [ Time Frame: Up to 6 years ]
• Proteomic profile [ Time Frame: Up to 6 years ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
• Official Title: Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
• 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.

Detailed Description

OUTLINE:

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

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood and tissue

• Sampling Method: Non-Probability Sample
• Study Population: Patients with prostate or bladder/urothelial cancer treated in genitourinary oncology practices at University of Washington Medical Center, Seattle Cancer care Alliance and Harborview Medical Center and healthy controls

Condition

• 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

Intervention

• Other: Cytology Specimen Collection Procedure
  Correlative studies
  Other Name: Cytologic Sampling
• Other: Laboratory Biomarker Analysis
  Correlative studies

Study Groups/Cohorts

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:

• Other: Cytology Specimen Collection Procedure
• Other: Laboratory Biomarker Analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 21, 2021): 1500
• Original Estimated Enrollment (submitted: January 14, 2010): 100
• Estimated Study Completion Date: January 31, 2029
• Estimated Primary Completion Date: January 31, 2029 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Robert B. Montgomery; 206-598-0856; rbmontgo@uw.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01050504
• Other Study ID Numbers: 6932; NCI-2014-01087 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 6932p; 6932 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); RG1712006 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); P50CA097186 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Washington
• Original Responsible Party: R. Bruce Montgomery, MD, Associate Professor, University of Washington, University of Washington
• Current Study Sponsor: University of Washington
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Robert B. Montgomery; Fred Hutch/University of Washington Cancer Consortium

• PRS Account: University of Washington
• Verification Date: January 2024