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BRIEF TITLE: Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy


  • Org Study ID: 6932
  • Secondary ID: NCI-2014-01087,6932p,6932,P30CA015704
  • NCT ID: NCT01050504
  • NCT Alias:
  • Sponsor: University of Washington - Other
  • Source: University of Washington

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: August 2009 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: DNA genomic sequencing

Primary Outcome 1 - Time Frame: Up to 6 years

Primary Outcome 2 - Measure: Gene expression profile using microarray assays

Primary Outcome 2 - Time Frame: Up to 6 years

Primary Outcome 3 - Measure: Mutation mapping using the OncoMap and other genotyping techniques

Primary Outcome 3 - Time Frame: Up to 6 years

Condition:

  • Healthy Control
  • Localized Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Neoplasm in the Soft Tissues
  • Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Recurrent Bladder Carcinoma
  • Recurrent Prostate Carcinoma
  • Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Stage IV Bladder Cancer
  • Stage IV Bladder Urothelial Carcinoma
  • Stage IV Prostate Cancer

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
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Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Robert Montgomery

Role: Principal Investigator

Affiliation: Fred Hutch/University of Washington Cancer Consortium

Location

Facility Status Contact
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States
Recruiting Robert B. Montgomery
206-598-0856
rbmontgo@uw.edu