Research and 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 Emory Winship Cancer Institute 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 nurse 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.
For more detailed information (frequently asked questions) about clinical trials, go to the Clinical Trials FAQ page, or contact any of our research nursing staff.
Research Nursing Staff
The research nursing staff at Emory Urology has over 30 years of combined experience in urology at Emory. This experience and familiarity is important in providing proper care and communication throughout the study period. Please feel free to contact us at anytime if you have questions regarding participation.
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Beverly Lopez, RN
Urology Research since 1991
(404) 778-4162 |
Sandy Hedrick, RN
Urology Nurse since 1997
(404) 778-3882 |
The following studies are open for enrollment at this time:
Emory Urology Clinical Trials
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Prostate Cancer Trials
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| Prostate Cancer Tissue Bank |
ELIGIBILITY:
-Males having radical prostatectomy
EXCLUSION CRITERIA:
-Refusal to sign informed consent.
****At the time of surgery, the following must be sent with the specimen to pathology:
-Sterile urine specimen
-3 green top blood tubes
-2 red top blood tubes |
SPONSOR: None
PI: Andrew Young, MD PhD
Viraj Master, MD PhD 8-3859 PIC #10253
COLLABORATORS: Hunter T. Hardy, MD, Leland WK Chung, PhD, John A. Petros, MD
CONTACT: Kathy Lachenmyer, RN (8-3882)
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| FACBC PET Study for Detection and Staging of Recurrent Prostate Cancer |
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ELIGIBILITY:
-Suspected recurrent prostate carcinoma after presumed definitive therapy for organ confined disease as defined by:
1) ASTRO criteria of
a) 3 consecutive rises of PSA or earlier if clinically appropriate, and/or
b) Nadir + 2.0 after radiotherapy or cryo, and/or
2) > 0.3 after prostatectomy.
-> 1 yr post- prostatectomy or cryotherapy; > 2 yr post- brachytherapy or XRT (PSA bump)
-Bone scan negative for metastases
-Ability to lie still for 1 hour for PET scanning
EXCLUSION CRITERIA:
-Not a surgical or biopsy candidate |
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
PI: David Schuster, MD 8-5236
Peter Nieh, MD 8-5754 PIC # 10152
Viraj Master, MD, PhD 8-5881 PIC # 10253
CONTACT: Beverly Lopez, RN 8-4343 PIC # 1533
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| Bone markers in Hormone-refractory Prostate Cancer (HRPC) with bone mets on taxanes |
Collect serum of pts with HRPC and bone mets undergoing chemo with Docetaxel/Prednisone
EXCLUSION CRITERIA:
-Prior chemotherapy
TREATMENT:
Docetaxel 75q3w + Prednisone 10/d |
SPONSOR: Cell Genesys
PI: Wayne Harris, MD 8-1900 PIC #10571
CONTACT: Courtney Johnson, RN 8-3575 PIC # 20177
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G-0029 Asymptomatic Metastatic HRPC (bone)GVAX vs ChemoRx |
ELIGIBILITY:
-Asymptomatic met HRPC with bone mets
-Progressive disease by 1) rising PSA or 2) imaging (CT,MR, bone scan)
EXCLUSION CRITERIA:
-Prior vaccine
-Prior chemotherapy
-Bone metastasis pain (level 2 or higher pain medication)
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TREATMENT:
GVAX (CG1940 and CG8711) vs Docetaxel + Prednisone
SPONSOR: Cell Genesys
PI: Wayne Harris, MD 8-1900 PIC #10571
CONTACT: Courtney Johnson, RN 8-3575 PIC # 20177
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| G-0034 Symptomatic Metastatic HRPC Taxane-nave with Pain |
ELIGIBILITY:
-Symptomatic met HRPC with bone mets (level 2 pain medication)
-Progressive disease by 1) rising PSA or 2) imaging (CT,MR, bone scan)
EXCLUSION CRITERIA:
-Prior vaccine
-Prior chemotherapy |
TREATMENT:
Docetaxel + GVAX (CG1940 and CG8711) vs Docetaxel + Prednisone
SPONSOR: Cell Genesys
PI: Wayne Harris, MD 8-1900 PIC #10571
CONTACT: Courtney Johnson, RN 8-3575 PIC # 20177
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| Cognitive Function, Memory and Depression in Patients Taking Lupron for Metastatic Prostate Cancer |
ELIGIBILITY:
-Age > 50
-Metastatic prostate cancer
-Already decided to go on leuprolide (Lupron) therapy
EXCLUSION CRITERIA:
-Prior LHRH agonist therapy (i.e. Lupron or Zoladex) |
TREATMENT:
Participants will go to Wesley Woods Health Center for a baseline visit before having the first Lupron injection. There will be another follow-up visit at Wesley Woods in 6-8 weeks. At each of the visits to Wesley Woods, questionnaires and tests of neuropsychological function, mood, sleep and quality of life will be administered. The time involved for these tests is about one hour each visit. The Lupron injection will be given at the Emory Clinic, Department of Urology, after the first visit to Wesley Woods and will take about 15 minutes.
PI: Chad Ritenour, MD , Fuqua Center for Late-Life Depression
CONTACT: Kathy Lachenmyer, RN (8-3882)
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Bladder Cancer Trials
| Hexvix |
Phase III Randomized Study of Hexvix Fluorescence Cystoscopy vs White Light Cystoscopy For Early Recurrence Bladder Cancer
ELIGIBILITY:
-Multiple tumors diagnosed at time of cystoscopy (no history of TCC), OR
-Recurrence of single tumor within 12 months of superficial bladder cancer resection, OR
-Recurrence of multiple tumors at any time after superficial bladder cancer resection
EXCLUSION CRITERIA:
-Gross hematuria
-BCG or intravesical chemotherapy within 3 months(may have single post-resection instillation)
-Tumors of distal or prostatic urethra
-Porphyria
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TREATMENT:
To evaluate use of Hexvix intravesical agent combined with fluorescence cystoscopy versus white light cystoscopy to determine differences in recurrence rates for superficial bladder cancer. Randomized trial; Hexvix instilled 1 hour prior to procedure; white light cystoscopy mapping, then randomized to routine biopsies or proceed with blue light cystoscopy mapping.
SPONSOR: PhotoCure and Storz
PI: Chad Ritenour, MD (PIC # 11015)
CONTACT: Beverly Lopez, RN 8-4343 or PIC # 15333
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Renal Cancer Trials
| Renal Tissue Bank |
ELIGIBILITY:
-Any solid renal neoplasm including oncocytoma, papillary renal cell carcinoma and transitional cell carcinoma of the kidney (renal pelvis/calyx, etc.)
-Biopsy specimens are ok also as long as no additional biopsies are taken just for research.
EXCLUSION CRITERIA:
-Refusal to sign the consent form.
****At the time of surgery, the following must be sent with the specimen to pathology:
-Sterile urine specimen
-3 green top blood tubes
-2 red top blood tubes
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SPONSOR: To be determined
PI: Andrew Young, MD PhD
COLLABORATORS: Fray F. Marshall, MD, John A. Petros, MD, Jonathan W. Simons, MD, Hunter Hardy, MD
CONTACT: Kathy Lachenmyer, RN (8-3882)
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| HIC # 781-2004 Obesity, Nutrition and Renal Cell Carcinoma in Blacks and Whites |
ELIGIBILITY: Volunteers must have renal cell carcinoma (a type of kidney cancer) and, if surgery has been done, be at least 6 months past surgery.
TREATMENT: The goal of this study is to find out if obesity, eating habits, smoking and other ways people live are responsible for differences in kidney cancer rates and trends between blacks and whites. People who volunteer for this study will have height, weight and body mass measurements taken and be interviewed by a registered dietician. |
PI: John Pattaras, M.D.
CONTACT: Beverly Lopez, RN (404) 778-4162
Fax: (404) 778-4006
Email: Beverly.lopez@emoryhealthcare.org
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Adjuvant RCC
G250 MoAb
A Randomized Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk Of Recurrence |
ELIGIBILITY:
-Clear cell ca
-Regional lymphadenectomy
-pT3b, pT3c, or pT4 N0M0
-Any T with N+
-pT1b or T2 with microscopic vascular invasion and Fuhrman > 3,
or T3a and Fuhrman > 3.
EXCLUSION CRITERIA:
-Non clear cell |
TREATMENT:
Randomized to receive weekly cG250 or placebo for 24 weeks.
SPONSOR: Wilex
PI: Peter Nieh, MD PIC # 10152
Wayne Harris, MD 8-1900 PIC #10571
CONTACT: Beverly Lopez, RN 8-4343 PIC # 15333
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Adjuvant RCC
E-2805
A Randomized Double Blind Phase III Study To Evaluate Adjuvant Sunitinib vs Sorafenib vs Placebo In Patients With Clear Cell RCC And High Risk Of Recurrence |
ELIGIBILITY:
-Clear cell and non-clear cell (except collecting duct or medullary)
-Pre-op: >cT1b N0 (or fully resectable N1-2 nodes) M0
-Post-op: pT1b G3-4, pT2-4 (any G) N0 or >pT1b (any G) N(any G, fully resected) M0
EXCLUSION CRITERIA:
-Collecting duct or medullary
-Distant metastases
-Significant cardiovascular disease (severe HT, MI, unstable angina, CHF, cardiac arrhythmia, or peripheral vascular disease)
-HIV |
SPONSOR: ECOG
PI: Wayne Harris, MD 8-1900 PIC # 10571
CONTACT: Courtney Johnson, RN 8-3575 PIC # 20177
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| Arcelis Trial: Dendritic Cell Vaccine Therapy |
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ELIGIBILITY:
-Newly diagnosed advanced RCC pre- or post-nephrectomy
Any T, any N, M1
Any T, N2 with indicator nodal metastasis, M0
Clear cell predominantly
-Planned nephrectomy within 1 mo (synchronous metastasis) OR Lesion accessible for excisional biopsy/metastasectomy (synchronous or metachronous metastasis) within 1 mo AND stable (progression/recurrence free) for > 3 mo after nephrectomy
-Measurable lesion > 1.0 cm remains after nephrectomy (bone excluded) as indicator lesion
-ECOG 0,1
-No brain mets on MRI
-Prior systemic therapy OK if stable for 3 mo after nephrectomy AND stable off systemic therapy >6 wks
EXCLUSION CRITERIA:
-Non-clear cell histology
-Bilateral nephrectomy
-Serious medical condition
-DM type I (insulin for type II OK)
-Active autoimmune disorders (e.g. RA, inflammatory bowel disease, SLE, MS)
-Planned excision/treatment of indicator lesion during study |
TREATMENT:
Tumor (nephrectomy or metastasectomy) and leukaphersis collections followed by dendritic cell vaccine production. Induction period (24 weeks): vaccine q2 weeks x 5, q4 weeks x 4. Booster period: vaccine q 3 mo until confirmed progression.
SPONSOR: Argos Therapeutics
PI: Viraj Master, MD, PhD 8-5881 PIC # 10253
CONTACT: Beverly Lopez, RN 8-4343 PIC # 15333
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Urinary Incontinence
| Study of Duloxetine HCL in Women of Different Demographic Characteristics and Co-Morbidities with Stress Urinary Incontinence: Evaluation of Efficacy and Safety |
ELIGIBILITY:
-Ambulatory women 18 years and older
-IEF>1 (SUI) if MUI-then SUI>2X UUI
-Discrete incontinence episodes for > 3 months
-English or Spanish Speaking
EXCLUSION CRITERIA:
-Pregnancy and UTI
-Advanced POP
-Disorders of the genito-fistula, persistant or recurrent UTI
-MAOI's
-Severe allergies/pregnancy/breastfeeding
-Significant CV disease
-Active Seizure or Liver disorder
-Unstable medical conditions or RX regimens
-Alcohol or drug abuse
-Investigator opinion
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TREATMENT:
The patient is screened with labs and questionnaires and returns in two weeks to qualify (per labs) and receive medication. They have 2 more visits each four weeks apart. The study medication is given for 8 weeks only. The patient must complete diaries and return at each visit along with their medication.
SPONSOR: Eli Lilly
PI: Niall T.M. Galloway, FRCS, FRCSE
CONTACT: Beverly Hunter RN 8-4162 PIC # 15333
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Stones
| Effect of Cola on Urinary Stone Risk Factors |
ELIGIBILITY:
-18 years old and above
-12 Normal subjects
-12 patients with a history of calcium oxalate urinary stones
EXCLUSION CRITERIA:
-< 18 years old
-Recurrent or active UTI
-Renal tubular acidosis
-Primary hyperparathyroidism
-Hyperkalemia
-Disease affecting acid-base status
-Gouty diathesis
-GI disease
-Renal insufficiency
-Chronic diarrhea
-Pregnancy/nursing
-Patients with hypercalcemia, calcium phosphate stones, stuvite stones, and uric acid stones
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TREATMENT:
This study has two phases, each lasting six days in duration. There is a 3 week wash out period between phases. The first phase consists of the pt picking up frozen meals and drinks (either cola only or cola and water) for days 1-4. Days 5-6 the patient will be admitted to the GCRC for meals, drinks, blood draw and 24 hour urines times two. The second phase begins when the patient picks up another four days of meals and drinks provided by the GCRC. Days 5-6 the patient will be admitted for another 48 hour stay in the GCRC where the same procedures will be repeated.
SPONSOR: Emory University Dept of Medicine/Dept of Urology
PI: Ken Ogan, MD PIC# 10193,
(CO-PI) John Pattaras, MD PIC # 11083
CONTACT: Beverly Hunter, RN 8-4162
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| The Effects of Ureteral Stent Length on Patient Symptoms |
ELIGIBILITY:
-Male or female, 18 years or older, able to give consent
-Renal or Ureteral calculi undergoing ureteroscopy
EXCLUSION CRITERIA:
-Patient unable to give consent
-Patient unable to complete questionnaires
TREATMENT:
The patient gives consent and completes the first of three questionnaires. The coordinator of the study will take measurements of the patient-ht, wt, bmi, pubic, waist. Also decide whether the patient is an endomorph, mesomorph or ectomorph. Patient is randomized to one of two groups. A) stent placement of equal length to that measured with the cath B) stent placement of 4 cm greater than measured with the cath.
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The stent will be left in for seven days. When the patient comes in for removal, the second questionnaire is completed BEFORE the stent is removed. The last questionnaire is completed one month from stent placement (or 3 weeks from stent removal). If the patient has an appt with the doctor it can be done then. Otherwise give the patient the last questionnaire and have the patient mail it back.
SPONSOR: Dept of Urology/Emory School of Medicine
PI: John G Pattaras, MD PIC # 11083
Ken Ogan, MD PIC # 10193
CONTACT: Beverly Hunter, RN 8-4162
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