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Please contact James Owen via e-mail or call him directly at 404-778-5429.

Research & Clinical Trials

Clinical trials are studies that are performed to try to demonstrate the effectiveness of new therapies compared to existing standard treatments. While the terms "investigational" or "experimental" may be used, these studies have been selected because of potential benefit with reasonable side effects, have been extensively researched in pre-clinical or limited clinical trials, have been reviewed by the Emory University Institutional Review Board for informed consent, will be carefully monitored for safety and response, and will provide the foundation for future treatment of urologic conditions, whether benign or malignant. For urinary tract tumors, the Emory Urology team works with colleagues in Medical Oncology and Radiation Oncology in the Winship Cancer Institute of Emory University for comprehensive oncologic care. Clinical trials are constantly being closed (completed) and opened (started), so periodic discussions with your urologist will keep you updated about the latest studies that might be appropriate for you.

Participating in a clinical trial begins with a discussion between the patient and physician. If there is further interest, additional discussions are started with the research coordinator and a screening is completed to qualify the patient. Once qualified, the patient is asked to sign an informed consent and discuss the study with family members or primary physician. Clinical trial patients have direct access to the research staff to answer any questions before, during or after a study.

Participation is voluntary and will not affect the quality of care you receive at Emory Urology.

The following studies are open for enrollment at this time.  For information on enrollment, please contact one of our research staff below.

Research Staff

The research staff at Emory Urology has a key role in providing proper care and communication throughout the study period. Please feel free to contact us at anytime if you have questions regarding participation.

Mersiha Torlak

Mersiha Torlak, MPH, CCRP
Associate Director of Research Projects
mhotic@emory.edu
404-778-4823
404-778-4006 Fax

 

spetka_stephanie

Stephanie Spetka, BS
Clinical Research Coordinator
stephanie.m.spetka@emory.edu
404-778-4162
404-778-4006 Fax

 

Bausum Photo

Anna Bausum, BS
Clinical Research Coordinator
abausum@emory.edu
404-778-4538
404-778-4006 Fax

 

Schwarts Photo

Rachel Schwartz, BS
Clinical Research Coordinator
rachel.schwartz@emory.edu
404-778-3038
404-778-4006 Fax

 

patil_datta

Dattatraya "Datta" Patil, MBBS, MPH
Biostatistician
dattatraya.patil@emory.edu
404-396-4638
404-778-4006 Fax

 

Address
Research & Clinical Trials 
Department of Urology
Emory University School of Medicine
1365B Clifton Road NE, Suite 1400
Atlanta, GA 30322
404-778-4006 Fax

Prostate Cancer - Screening Preparation Tool (PCSPrep)

This study utilizes eHealth Technology as a tool to standardize prostate cancer information conveyed to men eligible for prostate cancer screening. The purpose of the study is to standardize the process and minimize disparities in the information so to assist men make the appropriate informed decisions.

ELIGIBILITY
:
• African American men eligible for prostate cancer screening
• 40-70 years of age
• English speaking

EXCLUSION CRITERIA:
• History of prostate cancer screening within the past 5 years
• Established diagnosis of prostate cancer
• Psychiatric illnesses (major)
• Cognitive challenges/impairment

Principal Investogator:
Dr. Sanda

Co-Investigators & Collaborators
:
Dr. Master

Prostate Cancer - Decision Making (P3-P)

Personal Patient Profile - Prostate (P3-P) II: An Effectiveness-Implementation Trial in Diverse Health Care Networks

ELIGIBILITY
:
• Recent biopsy proving diagnosis of prostate cancer, T1 or T2 of any risk level
• No managment decisions or plans have been formulated or implemented
• Has made an appointment with a consulting specialist at enrolling study site
• Able to read, write, understand English

EXCLUSION CRITERIA:
• Multiple post biopsy consult visits to specialists
• Active survelleince for prostate cancer
• Treatment for prostate cancer

TREATMENT
:
This is a trial to assess the effectiveness of a decision support tool, the Personal Patient Profile, among men who are making decisions about their treatment and care for localized prostate cancer.

Principal Investogator:
Dr. Sanda

Co-Investigators & Collaborators
:
Dr. Master

Prostate Cancer - Imaging Study (FACBC PET)

Transmolecular Imaging of Recurrent Prostate Carcinoma with Exploration of Genomic Markers differences between Local and Distant Recurrence

ELIGIBILITY:
• Patients originally diagnosed with localized (T1c, T2 or T3) prostate cancer who had definitive therapy for prostate cancer (brachytherapy, cryotherapy, or external beam radiation therapy) but not prostatectomy
• Rising PSA resulting in suspicion that prostate cancer has returned

EXCLUSION CRITERIA:
• Less than 1 year since cryotherapy or 2 years since brachytherapy or external beam radiation
• Bone scan finding indicate metastatic prostate cancer 

TREATMENT:
After routine imaging studies (bone scan, CT pelvis, Prostascint scan), FACBC PET scan will be performed. Then, active sites within prostate bed or extraprostatic will be biopsied.

SPONSOR: NIH

Principal Investogator: Dr. Schuster

Co-Investigators & Collaborators: Dr. Nieh, Dr. Master

Prostate Cancer - Tissue Bank

Prostate tissue and specimen bank at Emory University and affiliated medical centers

ELIGIBILITY:
• Male undergoing prostate cancer screening or prostate 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 pathology department 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 Investogator: Dr. Petros

Co-Investigators & Collaborators
:
Dr. Sanda, Dr. Master, Dr. Osunkoya, Dr. Shelton

Kidney Cancer - Immunotherapy (AGS 003-007 or ADAPT)

Phase III randomized trial of autologous dendritic cell Immunotherapy plus standard treatment of advanced renal cell carcinoma

ELIGIBILITY:
• Metastatic kidney cancer
• No prior systematic therapy (such as chemotherapy or immunotherapy) for kidney cancer
• Good surgical candidate for partial or cytoreductive nephrectomy
• Adequate hematologic (blood & marrow), kidney and liver functions

EXCLUSION CRITERIA
• History or known brain metastases
• Active autoimmune disease
• History of clinically significant cardiovascular conditions
• History of cancer in the past 3 years (except for skin cancer and adequately treated early stage breast cancer, superficial bladder cancer or non-metastatic prostate cancer)

TREATMENT:
After cytoreductive nephrectomy, patient will receive personalized immunotherapeutic therapy along with standard therapy for metastatic kidney cancer 

SPONSOR: Argos Therapeutics

Principal Investogator: Dr. Master

Co-Investigators & Collaborators: Dr. Pattaras, Dr. Ogan, Dr. Nieh, Dr. Carthon, Dr. Harris & Dr. Kucuk

Kidney Cancer - Chemotherapy (Axitinib)

Phase III randomized double-blind study of adjuvant Axitinib versus Placebo in kidney cancer patients at high risk of cancer recurrence

ELIGIBILITY:
• Newly-diagnosed kidney cancer treated with nephrectomy
>50% clear cell renal cell carcinoma (RCC) on histopathology
• Pathological stage pT2, pT3 or pT4
• Lymph node metastasis (pN0, pNx, pN1)
• No distance metastasis (M0)
• ECOG Performance Status 0-1
• Adequate hematologic (blood & marrow), kidney and liver functions

EXCLUSION CRITERIA
• Undefferentaited histopathology, sarcoma, collecting duct carcinoma or lymphoma
• Patients with metastases to the kidney
• History of other cancers within the past 5 years
Exceptions - skin basal cell carcinoma, skin squamous cell carcinoma or in-situ carcinoma of the cervix uteri that has been adequately treated with no evidence of disease recurrence for the past 12 months
• History of anti-angiogenic therapy
• Clinically significant cardiovascular conditions

SPONSOR: SFJ Pharma Ltd. on behalf of Pfizer

Principal Investogator: Dr. Master

Co-Investigators & Collaborators
:
Dr. Ogan, Dr. Pattaras, Dr. Nieh, Dr. Kucuk, Dr. Harris, Dr. Carthon

Kidney Cancer - Tissue Bank

Kidney tissue and specimen bank at Emory University and affiliated medical centers

ELIGIBILITY:
Any patient undergoing kidney cancer screening or kidney 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 pathology department 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 Investogator: Dr. Petros

Co-Investigators & Collaborators
:
Dr. Sanda, Dr. Master, Dr. Osunkoya, Dr. Shelton

Bladder Cancer - Gene Therapy (rAd-IFN-CS-002)

 Please note that patient accural for this study has been completed

Phase II, randomized, open label study to evaluate the safety and efficacy of rAd-IFN/Syn3 following intravesical administration in subjects with high grade, BSG refractory or relapsed non-muscle invasive bladder cancer (NMIBC)

ELIGIBILITY:
• High grade BCG-refractory or relapsed NMIB
• Able to undergo resection of bladder tumor prior to study start
• Absence of upper tract urothelial carcinoma
• Adequate hematologic, renal and hepatic functions

EXCLUSION CRITERIA:
• Current or previous evidence of muscle invasive or metastatic bladder cancer
• Current systemic treatment for bladder cancer
• Current or prior pelvic external beam radiotherapy
• Severe cardiovascular disease
• History of malignancy within 5 years(except treated bassal cell carcinoma or squamous cell carcinoma of the skin)

TREATMENT:
Patients will receive rAd-IFN/Syn3 a gene-based therapy designed to improve delivery of, and hence prolong the exposure of non-muscle invasive bladder cancer (NMIBC) cells to, interferon-alpha2b (IFNalpha2b).

Principal Investogator: Dr. Ogan

Co-Investigators & Collaborators:
Dr. Nieh

Bladder Cancer - 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 into 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 Investogator: Dr. Ogan

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

Bladder Cancer - 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 pathology department 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 Investogator: Dr. Petros

Co-Investigators & Collaborators
:
Dr. Sanda, Dr. Master, Dr. Osunkoya, Dr. Shelton

Urologic Surgery - Endoscopic Visualization & Outcomes (Water vs. Saline)

The effects of water versus saline on absorption rates and visualization during ureteroscopy

ELIGIBILITY:
• Adult patients meeting medical requirements to undergo ureteroscopy (diagnostic and /or treatment)
• Patient must be consentable or have legal representative sign the ICF

EXCLUSION CRITERIA:
• None

TREATMENT:
The purpose of this study is to determine if the use of water or saline during ureteroscopy, a procedure where a small ureteroscope is used to guide through the ureter and renal (kidney) collecting system, has any clinical implications such as improved visualization, decreased operative time and improved patient outcomes.

Principal Investogator: Dr. Ogan, Dr. Pattaras

Urologic Surgery - Perioperative Physical Activity (Pedometer)

Prospective randomized study of exercise in patients undergoing urologic surgery

ELIGIBILITY:
• Adult patients scheduled for operative procedure with an inpatient postoperative stay
• Willing and able to give blood samples, complete a questionnaire and fill out the step log

EXCLUSION CRITERIA:
• None

TREATMENT:
Patients are given a pedometer and asked to record their daily steps in a log. The purpose of this study is to determine if we are able to increase patients’ physical activity in the perioperative period with the aide of pedometers

Principal Investogator: Dr. Ogan, Dr. Master, Dr. Pattaras, Dr. Nieh

Urologic Surgery - Frailty Study

This study investigates fraility as a predictor of outcomes in patients undergoing major surgical procedures. The purpose of this study is to understand and quatitate the impact of frailty as a pre-operative risk criteria. This information would assist both surgeons and patients in optimizing management decisions in the future. 

ELIGIBILITY
:
• Patients scheduled to undergo major surgical procedures (urologic, colorectal, intra-abdominal and/or vascular)
• Patients willing to do the study preoperative assessment tools

EXCLUSION CRITERIA:
• Cognitive disorders (dementia, CVA, etc.)
• Neurologic disorder with functional motor disorder (Parkinson's disease, multiple sclerosis, stroke, etc.)
• Depression treated with antidepressant medications
• Patients taking Carbidopa, Levodoa or Donepezil

Principal Investogator:
Dr. Ogan, Dr. Master

Co-Investigators & Collaborators
:
Dr. Pattaras, Dr. Nieh, Dr. Sweeney, Dr. Kooby, Dr. Maithel, Dr. Arya

Urologic Surgery - Tissue Bank

Urological tissue and specimen bank at Emory University and affiliated medical centers

ELIGIBILITY:
The study is open to all patients (men & women) undergoing evaluation for surgical treatment/removal of urologic organs and tissue. This includes:
• Men - kidneys, bladder, prostate, seminal vesicles & lymph nodes
• Women - kidneys, bladder, uterus, ovaries, vaginal tissue, fallopian tubes & lymph nodes

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 of the urologic organ, all tissue will be processed by the pathology department for routine standard histopathological examination. For the Specimen 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 Investogator: Dr. Petros

Co-Investigators & Collaborators
:
Dr. Sanda, Dr. Master, Dr. Osunkoya, Dr. Shelton

Urology Conditions