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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 312 694 2417
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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 312 695 8146
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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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312 695 8146
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CIRB: SWOG 1602 A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
The purpose of this study is to test two things:• Compare any good and ba…
The purpose of this study is to test two things:• Compare any good and bad effects of using the Tokyo-172 version of BCG with thecurrently used BCG LIVE (TICE® BCG) version of BCG on people with bladdercancer receiving BCG in the bladder. The study will be considered successful ifapproximately the same number of patients who receive the different treatments arefree from high grade recurrence of their bladder cancer after one year of treatment.• Using the Tokyo-172 version of BCG, compare any good and bad effects of adding aBCG vaccination (given under the skin) in addition to placing BCG in only thebladder. The study will be considered successful if the vaccination results in an 8%improvement in the number of patients who are free from high grade recurrence oftheir bladder cancer after one year of treatment.
Some of the eligibility criteria include: - Participants must have high grade bladder cancer thathas not entered the muscle - Participants must be 18 or older - 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.
Meeks, Joshua JMeeks, Joshua J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03091660 STU00205010
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Study Coordinator 312 695 1102
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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 of…

This research is being done to test the effectiveness (anti-tumor activity) and safety of combining enzalutamide with LY2157299 for the treatment of men with advanced castrate-resistant prostate cancer. 

Enzalutamide blocks testosterone production in the body to slow or stop the growth of prostate cancer cells. Enzalutamide (Xtandi®) is approved by the FDA for the treatment of patients with advanced castrate resistant prostate cancer who have received chemotherapy. 

LY2157299 is an investigational drug that inhibits a growth factor that is believed to play a role in the spread of the cancer. The use of LY2157299 in this research study is investigational. The word “investigational” means that LY2157299 is not approved for marketing by the Food and Drug Administration (FDA).

You may be eligible for this research study if you are a man with advanced castrate resistant prostate cancer.

Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000417 STU00205208
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Study Coordinator 312 695 1102
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DRUG CA209-914: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

The purpose of this study is to test the effectiveness (how well…

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return. 

Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. 

OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung, in multiple countries including the United States, the European Union, and Japan. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The combination of nivolumab (Opdivo™) and ipilimumab (Yervoy™) is also approved by the US FDA for the treatment of advanced kidney cancer that has spread to other parts of the body and by the US FDA and the EMA for the treatment of metastatic melanoma.

You may be eligible for this research study if you have kidney cancer and have had your tumors completely removed but are at risk of having your cancer return.

Sosman, JeffreySosman, Jeffrey
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03138512 STU00205491
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Study Coordinator 312 695 1102
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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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For more information on this study please contact us:

Study Coordinator 312 695 1102
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NU 17U19: Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer

This study will help researchers understand what men go through when being treated for their cancer. Specifically, the purpose of this study is to:

1. Assess the way men think during treatme…

This study will help researchers understand what men go through when being treated for their cancer. Specifically, the purpose of this study is to:

1. Assess the way men think during treatment for prostate cancer during specific treatments for prostate cancer.

2. Follow the thinking process during prostate cancer treatment over time.

3. Identify genetic variations that might make men more or less sensitive to thinking changes during treatment for prostate cancer. Genes are the instruction manual for your body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person’s risk for certain diseases and how they will respond to treatment. 

You may be eligible for this research study if you have prostate cancer and are interested in helping researchers understand what men go through when being treated for their cancer. 
Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03016741 STU00206082
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Study Coordinator 1 312 695 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 312 694 2417
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Shared Decision Making in Advanced Prostate Cancer
This study will help researchers understand what men go through when makingdecisions for treating their cancer. Specifically, the purpose of the study is to: 

1. Assess the treatment decision making process of men with advanced prostate cancer…

This study will help researchers understand what men go through when makingdecisions for treating their cancer. Specifically, the purpose of the study is to: 

1. Assess the treatment decision making process of men with advanced prostate cancer. 

2. Determine whether the amount of patient participation in decisions affects patientoutcomes, such as quality of life and satisfaction with the decision. 

3. Help researchers learn how to make treatment decision-making easier and lessconfusing for men with prostate cancer.

You may be eligible for this research study if you have prostate cancer and are interested in helping researchers understand what men go through when making decisions for treating their cancer.

Morgans, AliciaMorgans, Alicia
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206080
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For more information on this study please contact us:

Study Coordinator 1 312 695 1102
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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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For more information on this study please contact us:

Study Coordinator 312 695 1102
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NU 18U07: Clinical, Environmental, Genetic and Genomic Profile of Men with Early-Onset Aggressive Prostate Cancer

This study is being done because physicians do not completely understand the progressive biology of prostate cancer. Hence, the study aims to gather a better understanding of the clini…

This study is being done because physicians do not completely understand the progressive biology of prostate cancer. Hence, the study aims to gather a better understanding of the clinical and molecular features of prostate cancer patients who are younger than or equal to 60 years of age.

In this research project the researchers aim to characterize the different clinical, environmental, genetic and genomic profiles of men who present with early-onset (less than 60 years old) metastatic prostate cancer that spread to either lymphnodes or other parts of the body at diagnosis or who develop metastases shortly after local therapy. Specifically the investigators will collect information on race, ethnicity, family history, environmental, hormonal levels, metastatic disease extent and distribution. They will also evaluate the tumor tissue for genetic changes and correlate that with other clinical factors. The investigators will also determine if there are inherited genetic changes. Similarly for patients with spread prostate cancer who were treated with hormone therapy + docetaxel or abiraterone/prednisone with cancer progression (less than 1 year from start of therapy) and developed disease progression the investigators will assess clinical and genomic predictors of prostate cancer progression and resistance to therapy.

You may be eligible for this study if you are a male who has been diagnosedwith either advanced or metastatic prostate cancer. Advanced means that the cancer has spreadoutside the prostate gland including pelvic lymph nodes and metastatic means that the cancerhas spread to other parts of your body. 

One group of participants will be less than 60 years ofage with advanced or metastatic prostate cancer at diagnosis and the other group will be menwho have metastatic prostate cancer who were treated with hormone therapy with docetaxel orabiraterone/prednisone and the cancer is progressing.

Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207711
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For more information on this study please contact us:

Study Coordinator 1 312 695 1102
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NU 18U08: Targeting Chemokine Signaling and MAPK/ERK Pathway in Advanced Prostate Cancer

This is an observational study in which no treatment decisions will be made based on the findings of this study. This study is being done because physicians do not completely understand the progressive biology…

This is an observational study in which no treatment decisions will be made based on the findings of this study. This study is being done because physicians do not completely understand the progressive biology of prostate cancer. Hence, the study aims to gather a better understanding of some specific biomarkers (molecular markers) and their relation to the clinical picture of prostate cancer patients. The researchers aim to collect blood samples which will be used to evaluate biomarkers in Circulating Tumor cells (CTCs) and correlate their expression to disease prognosis (the likely course your disease will take) and response to therapy. They will collect information including age, race, ethnicity, family history of prostate cancer and other cancers, prostate cancer grade, tumor treatment, response to treatment, duration of survival and metastatic disease extent and distribution. 

A patient may be eligible for this research study if he has metastatic prostate cancer for which he will start hormone therapy (androgen deprivation therapy [ADT] plus abiraterone [Zytiga] if the cancer is castration sensitive, or with abiraterone or enzalutamide [Xtandi] if the cancer is castration resistant).

Hussain, MahaHussain, Maha
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207694
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For more information on this study please contact us:

Study Coordinator 1 312 695 1102
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