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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    300
  • sponsor
    University of Washington
Updated on 20 June 2021
platelet count
cancer
metastasis
bone metastases
transurethral resection

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

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.

Details
Condition Bone Metastases, 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, Recurrent Prostate Cancer, Stage IV Prostate Cancer AJCC v7, Bone Metastasis, Recurrent Bladder Cancer, Stage IV Bladder Urothelial Carcinoma AJCC v7, Malignant Solid Tumor, Malignant Solid Neoplasm, Metastatic Bladder Cancer, Stage IV Bladder Cancer AJCC v7, Metastatic Bladder Carcinoma, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, Localized Renal Pelvis and Ureter Urothelial Carcinoma, Recurrent Renal Pelvis and Ureter Urothelial Carcinoma
Treatment laboratory biomarker analysis, cytology specimen collection procedure
Clinical Study IdentifierNCT01050504
SponsorUniversity of Washington
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note