Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

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

Summary: This research trial 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: PRIMARY OBJECTIVES:
  I. Obtain tissue through tumor biopsies and/or surgical resection and matched blood samples from patients with localized and metastatic prostate and bladder/urothelial cancer for: mutation mapping using OncoMap and other high throughput genotyping technologies; sequencing of tumor genomic deoxyribonucleic acid (DNA); global assessment of gene expression to generate hypotheses that can be tested in subsequent trials (by gene expression microarrays and/or complementary [c]DNA sequencing; profiling of genes involved in androgen metabolism and DNA repair; quantitating peptides, hormones and other locally-derived or systemic metabolites present in tumor tissues.
  II. Obtain samples from controls, including blood or tissue for comparison with samples noted above.
  SECONDARY OBJECTIVES:
  I. Determine whether levels of other androgen synthetic enzymes predict responses to agents targeting the androgen-androgen receptor (AR) signaling axis.
  II. Determine whether intratumoral androgen levels are increased compared to serum levels, and whether they correlate with androgen synthetic enzyme levels and/or responses to therapy.
  III. Determine whether time to progression on therapy correlates with androgen biosynthetic enzymes or hormone levels.
  IV. Determine whether gene expression profiling can predict response and time to progression for chemotherapy or targeted agents.
  V. Identify immune B and/or T cell markers, sequencing and/or antibodies that may correlate with response, time to progression and/or overall survival for patients undergoing immunotherapy.
  OUTLINE:
  Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

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

Relevance to patient case: not relevant