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Bladder Cancer Trials

For enrollment information involving the following trials, please contact one of the research staff members on the "Meet the Team" page.

Genistein Therapy (GIBBS STUDY)

Surgical Resection (PK BUTTON)

Tissue Bank

GENISTEIN THERAPY (GIBBS STUDY)

Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravescial Therapy (GIBBS Study).

Eligibility:

• Male or female gender
• Non-invasive superficial bladder cancer
• Scheduled for BCG intravesical therapy
• Willing and able to fill out and complete a pill diary to ensure compliance

Exclusion Criteria:

• Pregnant patients
• Concurrent active second cancer (not history of cancer)
• HIV and/or immune-compromised patients
• Unwillingness to follow study protocol and compliance procedures

Treatment:

Patients will be randomized into Arm 1 (placebo) or Arm 2 (Genistein) at a ratio of 1:1, stratified by one dichotomized prognostic factor: age.

Patients are treated with intravesical therapy once a week for six weeks. When this stage is completed, they return to the office four weeks later for a post-operative visit and biopsy, as is standard care. Study subjects will take their pills for a total of 10 weeks, which includes the length of their treatment as well as the four weeks before the post-op visit.

Arm 1: BCG intravesical therapy with placebo pills for 10 weeks (44 subjects)

Arm 2: BCG intravesical therapy with 30 mg genistein supplements PO TID for 10 weeks (44 subjects)

Eligible Treatment Centers:

• The Emory Clinic
• Emory University Hospital
• Winship Cancer Institute

Principal Investigator: Dr. Kenneth Ogan

Co-Investigators & Collaborators: Dr. Viraj Master, Dr. John Pattaras, Dr. Peter Nieh

SURGICAL RESECTION (PK BUTTON)

PK Button Vaporization Electrode for Treatment of Bladder Tumors.

Eligibility:

• Cystoscopically detected blader tumors requiring TURBT
• Endoscopically resectable tumor(s) by surgeon's judgment with only one trip to the operating room

Exclusion Criteria:

• Clinical evidence of locally advanced, nodal, or metastatic bladder cancer
• Hydronephrosis secondary to bladder cancer
• Diffuse tumor throughout bladder that is deemed unresectable by surgeon

Treatment:

The goal of this study is to measure the procedural and long-term outcomes of Transurethral Resection of Bladder Tumor (TURBT) using the PK Button when compared to traditional monopolar loop electrocautery.

Sponsor: Olympus

Principal Investigator: Dr. Kenneth Ogan

Co-Investigators & Collaborators: Dr. Viraj Master, Dr. John Pattaras, Dr. Peter Nieh

TISSUE BANK

Bladder tissue and specimen bank at Emory University and affiliated medical centers.

Eligibility:

Any patient undergoing bladder cancer screening or bladder cancer treatment.

Eligible Treatment Centers:

• Emory University Hospital
• The Emory Clinic
• Emory Saint Joseph's Hospital
• Emory Midtown Hospital
• Grady Memorial Hospital

Exclusion Criteria

• None

Other Information:

• Following surgical removal, all tissue will be processed by the Department of Pathology for routine standard histopathological examination. For the tissue bank, a small portion of the tissue will be used for research testing.
• Additional specimens such as blood, urine, and saliva may be collected for research purposes.
• Patient medical records and test results will be reviewed and compiled in a relational database for research analysis.

Principal Investigator: Dr. John Petros

Co-Investigators & Collaborators: Dr. Martin Sanda, Dr. Viraj Master, Dr. Adeboye Osunkoya (Department of Pathology and Laboratory Medicine), Dr. Joseph Shelton (Department of Radiation Oncology)

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