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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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NU 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
Some of the eligibility criteria include:

- Participants must have a recurrent, high or low risk non-muscle-invasive bladder carcinoma.
- Participants must (be BCG refractory) have received at least one 6-week course of BCG induction plus 1 maintenance dose, OR 2 full 6-week courses of induction BCG treatment.
- 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
NCT02808143 STU00202754
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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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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, Edward MatthewSchaeffer, Edward Matthew
NCT03392181 STU00205957
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DRUG FOR46-001 - A Phase 1 Study of FOR46 Administered Every 21 Days in Patients with Metastatic Castration-Resistant Prostate Cancer (MCRPC)

The purpose of this study is to learn more about an experimental drug called FOR46 for Injection (also called “FOR46” or “study drug” in this consen…

The purpose of this study is to learn more about an experimental drug called FOR46 for Injection (also called “FOR46” or “study drug” in this consent form). FOR46 is an investigational medication, which means that it has not been approved by the FDA to be sold to the public.

FOR46 is being developed to see if it can treat metastatic prostate cancer. FOR46 is made up of an antibody (a type of protein) and an anticancer drug and is given intravenously (IV) (by vein). FOR46 is designed to travel through the bloodstream throughout the body and find cancer cells, and ultimately kill them or delay cancer growth.

During this study, the safety and anticancer activity of FOR46 will be evaluated, including looking for the highest dose level of FOR46 that can be taken safely. It is not known if there is a benefit to using FOR46 to treat metastatic prostate cancer in humans. In animal studies, FOR46 was found to be tolerated and able to kill prostate cancer cells and/or delay the growth of these cells. However, FOR46 has not yet been given to humans.

Males at least 18 years old who have metastatic prostate cancer.

VanderWeele, David JamesVanderWeele, David James
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT03575819 STU00209324
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Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer
Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat …
Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.
  • Participants must be 18 years orolder
  • Participants must be diagnosed with bladder cancer thathas not spread beyond the bladder.
Sachdev, SeanSachdev, Sean
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03775265 STU00210415
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PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated REnal Cell CancEr [PDIGREE]

This study is being done to answer the following question: Can we prolong life for patients with

advanced kidney cancer, by adding a drug…

This study is being done to answer the following question: Can we prolong life for patients with

advanced kidney cancer, by adding a drug called cabozantinib to another treatment after

receiving the standard treatment?

We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer.

-Participants must be 18 years of age or older

-Participants must be diagnosed with advanced kidney cancer

VanderWeele, David JamesVanderWeele, David James
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03793166 STU00210884
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RANDOMIZED PHASE II TRIAL OF NIRAPARIB WITH STANDARD COMBINATION RADIOTHERAPY AND ANDROGEN DEPRIVATION THERAPY (ADT) IN HIGH RISK PROSTATE CANCER (WITH INITIAL PHASE I)

The purpose ofthe study is to compare the usual treatment alone to using the study drug,Niraparib plus the usual treatment. Thea…

The purpose ofthe study is to compare the usual treatment alone to using the study drug,Niraparib plus the usual treatment. Theaddition of niraparib to the usual treatment could prevent your cancer fromgrowing or returning. But, it could alsocause side effects, which are described in the risks section below. The studydrug is not approved by the Food and Drug Administration (FDA) for use inpatients with prostate cancer.

There are twoparts to the study. The purpose of the first part is to assess whether it issafe to add Niraparib to the standard treatment by looking at whether thepatients treated experience side effects. This study will help identify thesafe initial dose that can be used in the second part of the study.

The second partstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach in preventing your cancerfrom growing or returning.

· Participants must be 18 years or older

Participants must have a confirmed diagnosis ofprostate cancer at a high risk or recurrance
Sachdev, SeanSachdev, Sean
  • Map it 251 E. Huron St.
    Chicago, IL
NCT04037254 STU00210909
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Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complications

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an offi…

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

This study will include allmen who are recommended to undergo prostate biopsy as part of routine clinicalcare.
Schaeffer, Edward MatthewSchaeffer, Edward Matthew
NCT03632655 STU00211699
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(xIRB) DRUG HPN424-1001: A Phase 1 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients with Advanced Prostate Cancer Refractory to Androgen Therapy

The purpose of this study is to test the safety and clinical eff…

The purpose of this study is to test the safety and clinical effects of an investigational drug known as HPN424 in patients with advanced prostate cancer. This drug has been tested in animals and this is the first study in which it is being tested in people. This study tests different doses of HPN424. We want to find out what effects, good and/or bad, it has on you and your cancer.

This study is comprised of a 28-day screening period, 21-day cycles of treatment, the End of Treatment/Safety Follow-Up and the Long-Term Follow-up. All patients enrolled in this study will receive the study drug (HPN424) once weekly for approximately 28 weeks. However, the length of your participation in the study may be shorter if you experience unacceptable side effects to the study drug, your cancer gets worse, you withdraw consent, or the sponsor ends the study early.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. HPN424 is an intravenous drug, meaning that it is given through a needle placed in your vein. HPN424 is intended to stimulate your own immune system to attack your body’s prostate cancer cells. The Treatment Period is divided into two parts:

Dose Escalation (Part 1): If you participate in Part 1, different doses of HPN424 will be given to study participants. The first patient in the first group will receive the lowest dose of the study drug. If the drug does not cause serious side effects, it will be given to other patients at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered.

All patients at each dose level will remain in the hospital for 48 hours following the first and second dose of the study drug so your study doctor can watch for any serious side effects.

Dose Expansion (Part 2): If you participate in Part 2, the same dose of HPN424 will be given to all study participants. Because the most well-tolerated dose will be determined in Part 1, the 48 hour- hospitalization following the first study drug dose is not required for any patients participating in Part 2.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete description of treatment.

Some of the eligibility criteria include:

• Diagnosis of prostate cancer that recurred after treatment with standard therapy, or prostate cancer that worsened while on treatment with standard therapy.

• Age of at least 18 years

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.

VanderWeele, David JamesVanderWeele, David James
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03577028 STU00212475
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DRUG ARV-110-mCRPC-101: A Phase 1/2, Open-label, Dose Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients with Metastatic Castration-resistant Prostate Cancer
The purpose of this research study is to assess…
The purpose of this research study is to assess the safety and tolerability of the investigational study drug (ARV-110) in men with metastatic cancer of the prostate which has progressed after multiple previous therapies. The study also seeks to evaluate how the drug moves within the body after administration (Pharmacokinetics {PK}) and what effects the drug has on your body after administration (Pharmacodynamics {PD}).

There are two parts to this study, Part A (dose escalation) and Part B (dose expansion). Your doctor will explain to you which part you are being considered for. Part B cannot start until Part A is completed.

After a screening period of up to 28 days, if you are eligible, you will receive study treatment in cycles of 28 days. You will be asked to take ARV-110 tablet(s) by mouth, once each day, or twice each day, with food. The study doctor will tell you what dose and how many times per day you should take your study medication. The number of treatment cycles depends on how well you will tolerate the study treatment and until you are no longer benefiting from the treatment (disease progression). Average participation in this study is expected to be between 6-9 months or in some cases may be longer.

After discussing with your study doctor, should you stop taking the study drug for any reason, the study center will continue to contact you every 3 months via phone or an in-office visit from the end of your treatment or follow up visit (which ever comes later) to see how you are doing.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

•Age of at least 18 years

•Diagnosis of metastatic cancer of the prostate which is resistant to hormone-based treatments, defined as castration-resistant.

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.

Hussain, MahaHussain, Maha
  • Map it 251 E. Huron St.
    Chicago, IL
NCT03888612 STU00212897
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(xIRB) DRUG ARC-6: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to understand whether an experimental treatment, AB928, is safe a…
The purpose of this study is to understand whether an experimental treatment, AB928, is safe and effective when given in combination with other treatments to patients with metastatic castrate resistant prostate cancer (mCRPC). AB928 may be combined with other experimental drugs, known as AB680 and zimberelimab (AB122), or may be combined with drugs that are approved by the US Food and Drug Administration (FDA) and other government agencies to treat mCRPC.

This is an open-label, randomized study. If you are eligible to participate in the study, you will be assigned to one of the following treatment arms based on your prior cancer treatment(s):

•AB928 + zimberelimab + enzalutamide (Stage 1 and Stage 2)

•Enzalutamide (Stage 2 only)

•AB928 + zimberelimab + docetaxel (Stage 1 and Stage 2)

•Docetaxel (Stage 2 only)

•AB928 + zimberelimab (Stage 1 and Stage 2)

•AB928 + zimberelimab + AB680 (Stage 1 and Stage 2)

•AB928 + AB680 (Stage 1 and Stage 2)

Depending on your past treatment history, the study doctor will help to decide which study treatment is best for you. You may be eligible for more than one study treatment. If this is the case, study treatment may be assigned randomly (by chance, like rolling dice). The study doctor can provide more detail on which study treatment(s) you may qualify for.

This study is made up of two stages. Regardless of which stage you are enrolled into, you will follow the same procedures as outlined below.

This research study is made up of the following parts:

•Screening

•Treatment

•End of Study and Long-Term Safety Follow Up

You will receive treatment depending upon the arm for which you qualify. The study drugs AB928 and enzalutamide are administered orally. The study drugs zimberelimab, AB680, and docetaxel are administered intravenously (IV) over approximately 1 hour.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

•Age of at least 18 years

•Diagnosis of metastatic castrate resistant prostate cancer

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.

VanderWeele, David JamesVanderWeele, David James
  • Map it 251 E. Huron St.
    Chicago, IL
NCT04381832 STU00213357
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(xirb) DRUG 7051-ONC-101: A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer
This research is being performed because improvements are needed in the management ofpatients with cancer. FT-7051 may help treat prostate cancer by blocking a receptor in the tumor c…
This research is being performed because improvements are needed in the management ofpatients with cancer. FT-7051 may help treat prostate cancer by blocking a receptor in the tumor cell, called theandrogen receptor. The major purpose of this study is to To test the safety of FT-7051 and see what effects (good and bad) it has on cancer, and to find the highest dose of FT-7051 that can be given alone without causing serious side effects. 

Some of the eligibility criteria include:

1. ≥ 18 years of age

2. Life expectancy of ≥ 3 months

3. Diagnosis of mCRPC with either adenocarcinoma or mixed histology

VanderWeele, David JamesVanderWeele, David James
  • Map it 251 E. Huron St.
    Chicago, IL
NCT04575766 STU00213972
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BTCRC GU19-404: A Single Arm, Phase I/II Trial of Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men with Localized, High Risk Prostate Cancer With Lead-In Cohort in Men with Castration Resistant Prostate Cancer

The purpose of this voluntary research study is to answer the foll…

The purpose of this voluntary research study is to answer the following questions:

•Phase I: Is it safe to combine drug called ipatasertib with androgen deprivation therapy (ADT) and a drug called darolutamide in men with prostate cancer?

•Phase II: Can combining a drug called ipatasertib with androgen deprivation therapy (ADT) and a drug called darolutamide for 6 months before surgery cause prostate cancer tumors to completely resolve or almost resolve?

Phase II will start after Phase I is finished.

If you are eligible and agree to participate, you will receive ADT as part of your usual care and the study drugs darolutamide and ipatasertib.

You will have tests, exams and procedures that are part of your regular care and for study purposes. After you stop the study drugs, your doctor will continue to watch you for side effects and follow your condition.

All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. Darolutamide and ipatasertib are pills taken by mouth. The drugs will be given in units of time called cycles. One cycle equals 28 days (4 weeks).

Phase I: The cycles will repeat until your cancer gets worse, or you have severe side effects. We expect that you’ll be in the study for 42 months (about 3½ years). You will have tests, exams and procedures that are part of your regular care and for study purposes. After you stop the study drugs, your doctor will continue to follow your condition for 1 month and watch you for side effects.

Phase II: The cycles will repeat until you receive 6 cycles of drug (about 6 months) until you have surgery to remove your prostate, or if your cancer gets worse, or you have severe side effects. We expect that you’ll be in the study for 30 months (about 2½ years).

You will have tests, exams and procedures that are part of your regular care and for study purposes. After you stop the study drugs, your doctor will continue to watch you for side effects and follow your condition every 6 months for 2 years.

Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Some of the eligibility criteria include:

•Age of at least 18 years

•Phase I: diagnosis of castrate-resistant prostate cancer.

•Phase II: diagnosis of localized, untreated prostate cancer with high risk features. Your tumor must also have a genetic change called PTEN loss.

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.

VanderWeele, David JamesVanderWeele, David James
  • Map it 251 E. Huron St.
    Chicago, IL
NCT04737109 STU00214064
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(xIRB) NCI CIRB ECOG-ACRIN 8183: A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

The purpose of thisstudy is…

The purpose of thisstudy is to compare Androgen Deprivation Therapy (ADT) alone to ADT plusdarolutamide for participants who have had surgery for prostate cancer. Thisstudy will help the study doctors find out if this different approach worksbetter than the approach of ADT alone. To decide if it is better, the studydoctors will be looking to see if the darolutamide increases the life of patientsby 6 months or more compared to the usual approach.

This study has 2groups. Participants will not be told which group they are in.

Group 1: Participantsin group 1 will get ADT plus a placebo pill for up to 12 months. A placebo is apill that looks like the study drug but contains no medication.

Group 2: Participants ingroup 2 will get ADT plus darolutamide. Darolutamide is not approved by the FDAfor treatment of this type of disease.

After study treatmentis finished, participants will be followed for 3-month intervals for 36 months towatch for side effects and disease progression.

Male participants ages 18 years or older who have had surgery forprostate cancer will be enrolled in this study.
Ross, Ashley EvanRoss, Ashley Evan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT04484818 STU00214490
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