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

Malignant Solid Neoplasm Clinical Trial

Official title:

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01050504
• Other study ID #: 6932
• Secondary ID: NCI-2014-0108769
• Status: Recruiting
• Start date: August 2009
• Est. completion date: January 31, 2029

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: Robert B. Montgomery
• Phone: 206-598-0856
• Email: rbmontgo[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

OUTLINE:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• 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
• Neoplasms
• Neoplasms, Second Primary
• Recurrence
• 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
• Ureteral Neoplasms
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA genomic sequencing		Up to 6 years
Primary	Gene expression profile using microarray assays		Up to 6 years
Primary	Mutation mapping using the OncoMap and other genotyping techniques		Up to 6 years
Secondary	Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction		Up to 6 years
Secondary	Proteomic profile		Up to 6 years