Genitourinary Cancer Clinical Trials

18 trials identified.

Patierno: Genomics of Prostate Cancer
Principal Investigator: Patierno, Steven
Protocol Number: PRO00053535

Age Group: Adult
Scope: National

Phase: N/A
Disease Site: Other Urinary; Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Prostate Cancer
What is the Purpose of this Study?
We are doing this study to learn more about the differences in prostate tumors between African Americans and Caucasians who have prostate cancer by looking at the genetic materials (DNA and RNA) in tumor tissue. 
Who Can Participate in the Study?
Adult patients with suspected or proven prostate cancer who are having a prostatectomy.
What is Involved?
If you choose to join this study, we will will collect tissue and blood at the time of your planned prostate surgery. 
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

PANTHER
Principal Investigator: George, Daniel
Protocol Number: PRO00075097

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Prostate Cancer
What is the Purpose of this Study?
We are doing this study to see if you take apalutamide, abiraterone acetate, and prednisone together, if it works in African American and Caucasian men with metastatic castrate resistant prostate cancer.   
Who Can Participate in the Study?
Adult patients with advanced prostate cancer that has spread beyond the prostate and has gotten worse after treatment with hormones (ADT).  
What is Involved?
If you choose to join this study, you will:  

Have a screening period that includes a physical exam, collection of demographic data, imaging scans, and blood draws.  

Once screening is complete, you will:
- Get the study drug apalutamide, abiraterone acetate, and prednisone over a period of 24 months
- Be asked to return to the clinic at least every four weeks for the first three months, and every three months thereafter
- At these visits, you will get a medical exam, answer questions about any medications or adverse events, have routine blood tests, and will also have imaging scans about every 3 months.  

After you finish all the study visits and have finished the study treatment, you will be contacted every 6 months to see how you are doing and to see what other cancer therapies you may be on.
Participating Institutions:
  • Chesapeake Urology Associates
  • Duke Cancer Center Cary : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Genitourinary Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Genitourinary Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Genitourinary Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Genitourinary Oncology DCI Clinical Research Team
  • Spartanburg Regional Healthcare System
  • Tulane
  • University of North Carolina
  • Virginia Oncology Associates
  • Wayne State University
View this trial at ClinicalTrials.gov

CTC - Immune Based Biomarkers
Principal Investigator: Zhang, Tian
Protocol Number: PRO00076768

Age Group: Adult
Scope: Local

Phase: N/A
Disease Site: Kidney; Prostate; Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Kidney and Bladder Cancer
What is the Purpose of this Study?
We are doing this study learn more about circulating immune cells and circulating tumor cells (CTCs) in patients with metastatic renal cell carcinoma or metastatic urothelial carcinoma.  

We are also looking at the bacteria in your gut and urinary tract to learn about how these bacteria affect how your cancer responds to immunotherapy.  
Who Can Participate in the Study?
Adult patients with renal or bladder cancer who are planning to start an immunotherapy.  
What is Involved?
If you choose to join this study, there will be four different timepoints.

At these timepoints, we will: 
- Collect blood, urine and stool samples
- Review your chart to find out how your body is reacting to the immunotherapy and how your cancer is responding to the immunotherapy.  

Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UNC Bladder (LCCC 1520)
Principal Investigator: Harrison, Michael
Protocol Number: PRO00077902

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Bladder Cancer
What is the Purpose of this Study?
We are doing this study to look at how adding pembrolizumab to standard of care, cisplatin and gemcitabine, may work to shrink your tumor before surgery.
Who Can Participate in the Study?
Adult patients with muscle invasive bladder cancer who are planning to have a surgery to remove the bladder (cystectomy).  
What is Involved?
If you choose to join this study, you will:  
- Enter a screening period that includes a physical exam, imaging scans, surveys, and blood draws

Once you have completed the screening period, you will:
- Get the study drug pembrolizumab on day 1 of each 3 week cycle along with standard-of-care gemcitabine and cisplatin on days 1 and 8.  
-- You will take study drugs for 12 weeks (4 cycles)
- Have blood draws, a physical exam, and be asked questions about the side effects you might had while taking the study drug
- Get a cystectomy (bladder removal surgery) after you have taken the study drug 
-- After your cystectomy, you will return to clinic for a post-surgery visit where you will be asked about your side effects.  
--Be followed for up to 5 years after your post-surgery visit. Each visit may include surveys about your quality of life, and imaging.
Participating Institutions:
  • Duke Cancer Center Cary : Genitourinary Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

STARTAR for prostate cancer
Principal Investigator: Zhang, Tian
Protocol Number: PRO00080868

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Prostate cancer with a rising PSA after prostatectomy
What is the Purpose of this Study?
We are doing this study to see if adding the study drugs apalutamide and docetaxel chemotherapy to a standard treatment for prostate cancer is more effective than the standard treatment alone.
Who Can Participate in the Study?
Patients with prostate cancer who have had a prostatectomy and whose PSA has started to rise after surgery. 
What is Involved?
If you choose to join this study, you will:

Enter a screening period that includes a physical exam, imaging scans, blood draws, and quality-of-life surveys. 

Once you've completed the screening period, you will 
- Receive the study drugs apalutamide and docetaxel in addition to standard-of-care androgen deprivation therapy (ADT) and radiation therapy over a period of 36 weeks. 
- Return to clinic at least every four weeks for exams, surveys and other procedures  

- Once you finish the study treatment, you will have follow-up visits every 3 months for 3 years
Participating Institutions:
  • Cornell
  • Duke Cancer Center Cary : Genitourinary Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
  • Urology Cancer Center &
  • GU Research Network
  • Wake Forest
View this trial at ClinicalTrials.gov

PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer (PICK NEPC)
Principal Investigator: Armstrong, Andrew
Protocol Number: PRO00080869

Age Group: Adult
Scope: Local

Phase: II (Cancer Control)
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Neuroendocrine prostate cancer
What is the Purpose of this Study?
We are doing this study to learn if it is safe and effective to give men with neuroendocrine prostate cancer avelumab.
Who Can Participate in the Study?
Adult males who have been diagnosed with neuroendocrine-like prostate cancer that have not been taking PD-1 inhibitors and/or 2 inhibitors, CTLA-4 inhibitors.
What is Involved?
If you join the study, you will have a screening period that includes a physical exam, imaging scans, blood draws, and collection of archival tumor tissue. 
After screening, you will:
- Come to the clinic to receive the study drug avelumab by IV infusion every 2 weeks.   
- Have medical exams, answer questions about any medications or adverse events, have routine imaging scans, have blood drawn for routine tests and research tests, and complete quality of life questionnaires.   
- Be asked for permission to have a tumor biopsy and donate some tissue to research when your cancer worsens.   
- Come to the clinic 28 days after the last dose of avelumab and then be followed every 3 months for up to 3 years.
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

GALAHAD- Advanced Prostate Cancer with a Particular Type of Genetic Mutation
Principal Investigator: George, Daniel
Protocol Number: PRO00081275

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced prostate cancer with a particular type of genetic mutation.  
What is the Purpose of this Study?
We are doing this study to see if niraparib is safe and effective for men who have advanced prostate cancer.
Who Can Participate in the Study?
Adult males who have prostate cancer with a particular type of genetic marker.
What is Involved?
If you agree to join this study, you will:
- Have a pre-screening period during which your tumor tissue and blood will be analyzed to see if your cancer has a mutation that may make it susceptible to niraparib.    

After pre-screening, you will:  
- Receive the study drug niraparib which you will take by mouth  
- Come to clinic every 2 weeks for the first 4 visits and every 12 weeks thereafter.    
- At each visit, you will have tests including labs and see a provider and study nurse.    
- Have imaging done every 8-12 weeks.     

You will receive the study drug (niraparib) as long as you are tolerating it
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Merck Prostate 365
Principal Investigator: Berry, William
Protocol Number: PRO00081276

Age Group: Adult
Scope: National

Phase: I/II (Cancer Control)
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Prostate Cancer
What is the Purpose of this Study?
We are doing this study to test the safety and how well these drugs work together in patients with metastatic castrate resistant prostate cancer.

Who Can Participate in the Study?
Adult patients with advanced prostate cancer that has spread beyond the prostate and has gotten worse after treatment with hormones (ADT).  
What is Involved?
If you choose to join this study, you will:  
- Complete a screening phase, that will include providing a tumor tissue sample, a physical exam, a blood draw, urine collection, an ECG, and imaging scans

Once you have completed the screening phase, you will: 
- Get the study drug Pembrolizumab every 3 weeks through an IV, while taking standard-of-care abiraterone with prednisone by mouth daily
- Return to the clinic every 3 weeks for study visits that will include a physical exam, questions about medications and side effects, study drug infusions, and blood and urine tests 
- Have Imaging scans that will be done every 9 weeks for the first year on the study then every 12 weeks

After you finish all the study visits and have finished the study treatment, you will be contacted every 6 months to see how you are doing and to see what other cancer therapies you may be on.
Participating Institutions:
  • Duke Cancer Center Cary : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Cancer Imaging using HS-196
Principal Investigator: Morse, Michael
Protocol Number: PRO00082272

Age Group: Adult
Scope: Local

Phase: I
Disease Site: Breast; Pancreas; Prostate; Unknown Sites

Contact: Hollister, Beth
Phone:

What is the Condition Being Studied?
Breast, Prostate, and Pancreatic Cancer Imaging
What is the Purpose of this Study?
We are doing this study to see if the study drug, HS-196, is safe and to see if there are any side effects that people may experience while taking it.

HS-196 is a drug which marks cancer cells and it may help doctors see the cancer during and after surgery.
Who Can Participate in the Study?
Adults who are having surgery for:
- Prostate cancer
- pancreatic cancer
- breast cancer 
What is Involved?
If you choose to join this study, you will:
- Be given the study drug, HS-196 by injection up to 36 hours before surgery
- Allow us to use your tissue that is removed for research
- Give blood on the day of the injection, day after injection, 1 week following injection, and 1 month following injection
Participating Institutions:
  • Duke Cancer Center Cary : Beth Hollister
  • Duke Center for Living/Sarah Stedman Nutrition : Beth Hollister
  • Duke Primary Care : Beth Hollister
  • Duke Private Diagnostic Clinic (PDC) : Beth Hollister
  • Duke Raleigh Hospital : Beth Hollister
  • Duke Regional Hospital : Beth Hollister
  • Duke University Health System : Beth Hollister
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Beth Hollister
  • Johnston Health (Smithfield) : Beth Hollister
  • Maria Parham Health (Henderson) : Beth Hollister
  • Scotland Health Care System (Laurinburg) : Beth Hollister
  • Southeastern Regional Medical Center (Lumberton) : Beth Hollister
View this trial at ClinicalTrials.gov

ECOG-ACRIN EA8143- Kidney Cancer
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00082493

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Kidney

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Kidney Cancer (Renal Cell Carcinoma)
What is the Purpose of this Study?
We are doing this study to see if the study drug Nivolumab taken before and after surgery for kidney cancer is better, the same, or worse than the standard follow-up after having had surgery for kidney cancer. 
Who Can Participate in the Study?
Adults with kidney cancer who:
- Have no prior therapy for the kidney cancer
- Have no autoimmune or liver disease
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will: 
- Be randomized (like a flip of a coin) get either:
-- Group 1: The study drug nivolumab by an IV through your vein before and after surgery once a month for a total of 10 doses
-- Group 2: Surgery followed by observation
- Have CT or MRI scans to monitor your status for up to 6 years 
- Have clinic visits every 6 months for 2-3 years and then  yearly for 4-5 years
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

INTERVAL - exercise in renal cell carcinoma
Principal Investigator: Harrison, Michael
Protocol Number: PRO00082941

Age Group: Adult
Scope:

Phase: N/A
Disease Site: Kidney

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Kidney Cancer (Renal Cell Carcinoma)
What is the Purpose of this Study?
We are doing this study to find out whether treatment with ipilimumab and nivolumab changes the physical fitness level and heart and vascular function in patients with advanced kidney cancer.  

We are also want to find out whether exercise testing can help physical fitness and quality of life in these patients.  
Who Can Participate in the Study?
Adult patients with kidney cancer who:
- Plan to get ipilimumab with nivolumab to treat kidney cancer that has spread beyond the kidney
- Are able to walk on a treadmill and meet certain physical parameters
What is Involved?
If you choose to join this study, you will:  
- Have a screening period where you will have a series of tests that will test how well your heart and vascular system are working and how physically fit you are.  

After the screening period, you will be randomized (like a flip of a coin) to either an exercise plan OR your usual activity. 

While you are active on study, you will:  
- Follow your activity plan for 12 weeks
- Have repeat testing of your heart and vascular system and physical fitness
- Have blood draws
- Have the option to participate in a 12-week home-based exercise program after you finish the plan for 12 weeks

You will only be involved in the study between 12 and 24 weeks. Your physician will work with you to find out how long you will get ipilimumab and nivolumab.  
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Genitourinary Oncology DCI Clinical Research Team
  • Duke Primary Care : Genitourinary Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

NRG-GU002 for Prostate Cancer
Principal Investigator: Lee, William
Protocol Number: PRO00083088

Age Group: Adult
Scope: National

Phase: II/III (Cancer Control)
Disease Site: Prostate

Contact: DCI Clinical Research Team, Radiation Oncology
Email:

What is the Condition Being Studied?
Prostate cancer which has been surgically removed
What is the Purpose of this Study?
We are doing this study to compare the effects of using docetaxel along with the radiation therapy and hormone suppression therapy to using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer coming back after surgically removing the prostate.
Who Can Participate in the Study?
Adult men who have prostate cancer and the prostate has been surgically removed:
- are 18 years or older
What is Involved?
If you agree to be in this study you will:
- Be randomly assigned (put into one of two groups by chance like a flip of a coin) and receive either:
Group 1 - continue to receive hormone suppression therapy and will get the usual radiation therapy used for prostate cancer
Group 2 - continue to receive hormone suppression therapy and get the usual radiation therapy used for prostate cancer followed by 6 doses of the chemotherapy drug docetaxel.
 - Receive hormone suppression therapy for a total of 6 months
 - See your doctors every 3 months for 2 years, then every 6 months for 3 years, and then yearly.
Participating Institutions:
  • Duke University Health System : Radiation Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

CC-115 for Prostate Cancer
Principal Investigator: George, Daniel
Protocol Number: PRO00084900

Age Group: Adult
Scope:

Phase: I
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Prostate Cancer
What is the Purpose of this Study?
We are doing this study to learn about the side effects that patients have when you take the two drugs enzalutamide and CC-115 together.  

We also want to learn whether these drugs will work as a treatment for prostate cancer. 
Who Can Participate in the Study?
Adult patients with advanced prostate cancer that has spread beyond the prostate and has gotten worse after treatment with hormones (ADT).  
What is Involved?
If you choose to join this study, you will:  
- Have a screening period that includes a physical exam, collection of demographic data, imaging scans, a tumor biopsy and blood draws.  

Once you have completed the screening period, you will:  
- Take the study drug CC-115 with standard-of care-enzalutamide that will be taken by mouth at home
- Be asked to return to clinic weekly for the first 4 weeks, then every 8 weeks. 
-- At these visits, you will get a medical exam, answer questions about any medications or adverse events, have routine blood tests
- Have imaging scans about every 2 months for the first 6 months and every 3 months after that.  
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Genitourinary Oncology DCI Clinical Research Team
  • Duke Primary Care : Genitourinary Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

EV-201 for Advanced Bladder Cancer
Principal Investigator: Harrison, Michael
Protocol Number: PRO00089691

Age Group: Adult
Scope: National

Phase: II
Disease Site: Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Bladder Cancer (Urothelial Cancer)
What is the Purpose of this Study?
We are doing this study to find out if enfortumab vedotin will work for patients with advanced urothelial cancer who have been previously treated with an immunotherapy.
Who Can Participate in the Study?
Adult patients with advanced bladder cancer who have gotten an immunotherapy but have not gotten chemotherapy.
What is Involved?
If you choose to join this study, you will:  
- Have a screening visit that includes a blood draw, urine collection, eye exam, and imaging scans

Once you have completed the screening phase, you will:
- Have physical exams, blood tests, questions about your medications and side effect, and an imaging scan will be done every 8 weeks at your study visits
- Get the study drug enfortumab vedotin as an infusion in 28 day cycles.  
-- You will get study drug on days 1, 8 and 15 of each cycle  
-- Each cycle will require at least 3 visits to Duke

As long as you are not experiencing major side effects and the imaging scans show that your cancer is under control, you will continue to have study visits and get the study treatment.  

After you finish all the study visits and have finished the study treatment, you will be contacted about every 3 months to see how you are doing and to see what other cancer therapies you may be on.
Participating Institutions:
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Alliance A031501 for Bladder Cancer
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00089733

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Bladder Cancer 
What is the Purpose of this Study?
We are doing this study to find out if the study drug MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach after surgery to remove muscle-invasive bladder cancer. 
Who Can Participate in the Study?
Adults who:
- Have recently had their bladder removed
- Have no active autoimmune disease
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:
-- Group 1: study drug MK-3475 (pembrolizumab) by intravenous infusion once every 3 weeks for one year
-- Group 2: no study drug but followed with clinic visits every 6 weeks for one year
- Get a CT or MRI scans every 12 weeks for 2 years and then yearly for up to 5 years 
Participating Institutions:
  • Duke Cancer Center Cary : Genitourinary Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

MK-7123 Study for Selected Advanced/Metastatic Solid Tumors
Principal Investigator: Armstrong, Andrew
Protocol Number: PRO00092175

Age Group: Adult
Scope:

Phase: II
Disease Site: Colon; Lung; Prostate; Rectum

Contact: DCI Clinical Research Team, Phase I Clinical Trials Office
Email:

What is the Condition Being Studied?
Non-small cell lung cancer, Prostate Cancer or Colorectal Cancer
What is the Purpose of this Study?
We are doing this study to see how Navarixin (MK-7123) given with pembrolizumab (MK-3475) works in your body and against your cancer.
Who Can Participate in the Study?
Adults who:
- Have been diagnosed with Non-small cell lung cancer, Prostate Cancer or Colorectal Cancer
-- Non-small cell lung cancer patients must have Stage IV disease and have progressed on PD-1 treatment
-- Prostate Cancer patients must have progressed on recent treatment and on at least one second generation anti-androgen therapy
-- Colorectal Cancer patients must have locally advanced unremovable or metastatic Stage IV disease and been treated with standard therapies
What is Involved?
If you choose to be in this study, you will:
- Be randomly assigned (like the flip of a coin) to one of two groups:
-- Group A: Take 30 mg Navarixin by mouth daily and Pembrolizumab into your vein every 3 weeks
-- Group B: Take 100 mg Navarixin by mouth daily and Pembrolizumab into your vein every 3 weeks
- Provide a prior tissue sample or fresh tumor biopsy before starting the study drug
- Provide multiple blood and urine samples during the study
- Have a series of tests and scans (Computerized tomography (CT) and/or Magnetic resonance imaging (MRI)) at the study center
- Take the study drug for about 2 years and then enter the follow-up period

Participating Institutions:
  • Duke Cancer Center Cary : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Primary Care : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Raleigh Hospital : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Regional Hospital : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke University Health System : Phase I Clinical Trials Office DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Johnston Health (Smithfield) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Phase I Clinical Trials Office DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Phase I Clinical Trials Office DCI Clinical Research Team
View this trial at ClinicalTrials.gov

BMS CA209-901: Advanced Bladder Cancer (Urothelial Cancer)
Principal Investigator: Harrison, Michael
Protocol Number: PRO00092363

Age Group: Adult
Scope:

Phase: III
Disease Site: Urinary Bladder

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Bladder Cancer (Urothelial Cancer)
What is the Purpose of this Study?
We are doing this study to find out how well the study drugs ipilimumab and nivolumab work with standard bladder cancer treatments.  

We also want to learn if taking these study drugs are safe and how they make you feel.
Who Can Participate in the Study?
Adult patients with advanced bladder cancer who are planning to start treatment with standard chemotherapy (gemcitabine with either cisplatin or carboplatin).
What is Involved?
If you choose to join this study, you will: 
- Have a screening period that will include a physical exam, imaging scans, and blood draws
- Let us send a tumor sample to be tested at an outside lab.  This sample may be a recently collected specimen already available or a new sample.  

Once you have completed the screening period, you will be randomized (like drawing numbers from a hat) to get one of the four possible drug regimens:
- Gemcitabine, cisplatin and nivolumab 
- Ipilimumab and nivolumab
- Gemcitabine and cisplatin
- Gemcitabine and carboplatin

While you are getting the study treatment, you will come back for study visits every 3 weeks, where you will: 
- Have a physical exam and lab work
- Be asked questions about medications and side effects
- Have imaging scans every 12 weeks

After you finish treatment, you will enter a follow-up phase.  Every 3 months, you will be asked about your current bladder cancer treatment and complete surveys.
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Genitourinary Oncology DCI Clinical Research Team
  • Duke Primary Care : Genitourinary Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10096 Olaparib and Radium-223 in mCRPC with Bone Metastases
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00101127

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Prostate

Contact: DCI Clinical Research Team, Genitourinary Oncology
Email:

What is the Condition Being Studied?
Advanced Prostate Cancer
What is the Purpose of this Study?
We are doing this study to find out if we can lower the chance of your prostate cancer growing or spreading by adding the study drug, Olaparib, with Radium-223 (the usual treatment).
Who Can Participate in the Study?
Adult males who:
- Have prostate cancer that has grown after initial treatment and has spread to the bone
- Are willing to have a biopsy and agree to use two forms of contraception while on study and for 6 months after the study
- Are able to take oral medications
What is Involved?
If you choose to join this study, you will:

- Provide a tissue sample leftover from your biopsy if you have it
OR
- Have a biopsy within 2 weeks before starting study drug

- Get the combination of radium-223 and olaparib
-- Radium-223 is given through your vein and will be given for up to 6 doses every 4 weeks
-- Olaparib will be in the form of pills given orally on a daily basis

- Have 1-2 blood tests every 28 days, plus one additional blood test at the end of the study
- Have a CT or MRI scan every 12 weeks
- Complete questionnaires to record your family history (at start of study only) and to record your function and pain level (every 12 weeks and at the end of study)
Participating Institutions:
  • Duke Cancer Center Cary : Genitourinary Oncology DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Genitourinary Oncology DCI Clinical Research Team
  • Duke Primary Care : Genitourinary Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Genitourinary Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Genitourinary Oncology DCI Clinical Research Team
  • Duke Regional Hospital : Genitourinary Oncology DCI Clinical Research Team
  • Duke University Health System : Genitourinary Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Genitourinary Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Genitourinary Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Genitourinary Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Genitourinary Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Genitourinary Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov