Clinical trial NCT01050504: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-15
Enrollment: 1500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: DNA genomic sequencing
timeFrame: Up to 6 years
measure: Gene expression profile using microarray assays
timeFrame: Up to 6 years
measure: Mutation mapping using the OncoMap and other genotyping techniques
timeFrame: Up to 6 years
Secondary outcomes:
measure: Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction
timeFrame: Up to 6 years
measure: Proteomic profile
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Robert B. Montgomery
role: PRINCIPAL_INVESTIGATOR
References: