Northwestern University Feinberg School of Medicine
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Polsky Urologic Cancer Institute

Clinical Trials

Clinical trials are research studies that help doctors find new and better ways to prevent and treat cancer. Almost every cancer treatment that is saving lives today is the result of a clinical trial. Search below to find clinical trials related to urologic cancer, visit the About Clinical Trials page on the Lurie Cancer Center website to learn more and talk with your doctor to decide if a clinical trial is right for you.

Trials
The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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Khawaja, Faizan
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Epigenetic Markers of Bladder Cancer Progression
The purpose of this study is to better understand the expression of certain genes and genetic changes that occur in bladder tumors.
Male or female patients aged 40-89 identified to have a bladder lesion or mass concerning for urothelial carcinoma based on cystoscopy or imaging who are scheduled to undergo transurethral resection of bladder tumor (TURBT).
Meeks, Joshua JMeeks, Joshua J
STU00088853
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Meeks, Joshua J
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NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
Some of the eligibility criteria include:

- participants must have been diagnosed with prostate cancer that is metastatic (has spread outside of the prostate region) and castration-resistant (means the cancer is still growing even when testosterone levels are close to zero)
- participants must be males 18 years of age or above

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03012321 STU00203960
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Study Coordinator 312 695 1102
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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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NU JH17U01: Overcoming drug resistance in metastatic castration-resistant prostate cancer with novel combination of TGF-β receptor inhibitor LY2157299 and enzalutamide: a randomized multi-site phase II study
This research is being done to test the effectiveness (anti-tumor activity) and safety ofcom…
This research is being done to test the effectiveness (anti-tumor activity) and safety ofcombining enzalutamide with LY2157299 for the treatment of men with advanced castrateresistant prostate cancer. 
Morgans, AliciaMorgans, Alicia
NCT00000417 STU00205208
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Study Coordinator 1-855-NU-STUDY
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Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the inter…
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous) through a vein. About 12 people are expected to participate in this research study here at Northwestern University out of 160 people in the entire study nationally.
Some of the eligibility criteria include:
• Participants must be 18 or older.
• Patient must have the ability to understand and sign an approved informed consent form (ICF).
• Patient must have a confirmed diagnosis of advanced Renal Cell Carcinoma (RCC).
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Sosman, JeffreySosman, Jeffrey
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03117309 STU00205969
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Study Coordinator 312 695 1102
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PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
Schaeffer, EdwardSchaeffer, Edward
NCT03392181 STU00205957
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Khawaja, Faizan
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(xIRB) NCI 9767: An Open Label, Multicenter, Single arm Phase II study to evaluate the Activity and Tolerability of the novel mTOR Inhibitor, MLN0128 (TAK-228), in patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the urothelial tract whose tumors harbor a TSC1 and/or TSC2 mutation.
The purpose of this study is to test any good and bad effects of the study drug called MLN0128 (TAK-228). This study is being done to see if MLN0128 (TAK-228) is effective in treating this type of cancer.
• Participants must be 18 years or older
• Participants must have a urinary tract cancer that has spread because the cancer has a mutation in TSC1 and/or TSC2 genes.
• Participants must have already been treated with chemotherapy, but their disease is still growing
Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03047213 STU00206603
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Study Coordinator 1-855-NU-STUDY
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Next-Generation sequencing of cell-free circulating tumor DNA in locally invasive bladder cancer
bloodstream. These pieces are called cell-free circulating tumor DNA (cfDNA). Recent studies in lung and breast cancers have shown that cfDNA can be screened for certain mutations to detect and follow t…
bloodstream. These pieces are called cell-free circulating tumor DNA (cfDNA). Recent studies in lung and breast cancers have shown that cfDNA can be screened for certain mutations to detect and follow the growth of a patient’s tumor. This study aims to apply this technique to bladder cancer and to identify specific mutations unique to varying stages of bladder cancer. This technology has been applied to other cancers but has not yet been studied in bladder cancer. We plan to determine whether this technology is able to identify genetic mutations linked to bladder cancer.
Patients age 18-89 years old with early invasive (T1) and muscle invasive (T2+) bladder cancer .
Meeks, Joshua JMeeks, Joshua J
STU00206645
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ATLAS: A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
The investigational drug being investigated in this study is called rucaparib (also known as CO-338 or Rubraca). Rucaparib is approved (trade name: Rubraca) in the US as treatment for …
The investigational drug being investigated in this study is called rucaparib (also known as CO-338 or Rubraca). Rucaparib is approved (trade name: Rubraca) in the US as treatment for patients with advanced ovarian cancer who have been treated with two or more chemotherapies and who have a certain type of abnormal BRCA gene. However, Rucaparib is not approved by the U.S. Food and Drug Administration (FDA) for use in people with urothelial carcinoma, which is why its use in this study is INVESTIGATIONAL and still being tested.

Rucaparib belongs to a class of anti-cancer agents known as PARP inhibitors (poly [adenosine diphosphate (ADP)-ribose] polymerase inhibitors). PARP is a protein inside cells that helps repair damage to DNA, which is the genetic material that carries the instructions for the body’s growth and development, and allows cells to continue on living. Cancer can result when there are changes in a person’s genetic material (sometimes called DNA mutations) that can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing.

The goal of this study is to evaluate the efficacy (how well the study drug works) and safety of rucaparib (the study drug) to determine whether rucaparib is a potential treatment option in people with urothelial carcinoma. The study will also evaluate the pharmacokinetics (also called PK) of the study drug. Pharmacokinetics is the way the body absorbs, distributes, and gets rid of a drug and provides information on the amount of study drug in the blood.

Some of the eligibility criteria include:• Participants must be 18 or older.• Patient must have the ability to understand and sign an approved informed consent form (ICF).• Patient must have a confirmed diagnosis of urothelial carcinoma.

Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

Morgans, AliciaMorgans, Alicia
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03397394 STU00207365
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For more information on this study please contact us:

1-855-NU-STUDY
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