Is NCT05726292 recruiting in Chicago, IL?

Yes, NCT05726292 is currently recruiting participants at its Chicago, IL location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in Chicago, IL

About This Prostate Cancer Study in Chicago

Researchers conducting this study hope to learn about the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, plus androgen deprivation therapy (ADT), also known as hormone therapy. This study is for individuals who have been diagnosed with advanced, high-risk prostate cancer and standard therapies available to treat your disease have not been effective. Participation in this research will last about 3 years and 9 months.

Sponsor: University of Chicago

Who Can Participate

Inclusion Criteria

Histologically or cytologically confirmed prostatic adenocarcinoma without primary small cell histology

Localized disease:

Surgical resectability must be documented prior to enrollment

No evidence of distant metastatic disease on abdominopelvic imaging, bone imaging

Enlarged lymph nodes below the iliac bifurcation (clinical stage N1) is allowed

Either cross-sectional abdominopelvic imaging + technetium bone scan or PSMA PET imaging will be acceptable to rule out distant metastatic disease

High or very high-risk disease (https://www.nccn.org/professionals/physician\_gls/pdf/prostate.pdf) as defined by having one or more of the following:

Clinical T3a or higher

Histologic Grade Group 4 or 5

Eastern Cooperative Oncology Group performance status ≤ 1 (Appendix A)

Total serum testosterone 100 ng/dL

Patients must have normal hepatic function as defined below:

Total bilirubin \<1.5 X the upper limit of normal (note that in subjects with Gilbert's syndrome, if total bilirubin is \>1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible)

AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal

Albumin 3.0 g/dL

Patients must have normal bone marrow function as defined below:

Platelet count (plt) 100,000 /L

Hemoglobin (Hgb) 10 g/dL

Absolute neutrophil count (ANC) 1500

Patients must have adequate renal function as defined below: • glomerular filtration rate (GFR) 30 mL/min

Ability to understand and the willingness to sign a written informed consent document.

Patients with active diabetes mellitus on glucose lowering medications are eligible provided they agree to and are able to self-monitor daily blood glucose levels due to potential risk of lowering glucose levels on relacorilant.

Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:

Condom (barrier method of contraception) AND

One of the following is required:

Established use of oral, injected or implanted hormonal method of contraception by the female partner;

Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner;

Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner;

Tubal ligation in the female partner;

Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months. 3.2

Exclusion Criteria

Therapy with ANY hormonal therapy for prostate cancer (prior 5-alpha-reductase inhibitors for benign prostate disease is allowed but must be discontinued prior to study initiation).

Inability to swallow capsules or known gastrointestinal malabsorption.

History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies that are without evidence of disease, or other cancers curatively treated with no evidence of disease for \> 5 years from enrollment.

Blood pressure that is not controlled despite \> 2 oral agents (SBP \>160 and DBP \>90 documented during the screening period with no subsequent blood pressure readings \>160/100).

History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.

Serious inter-current infections or non-malignant medical illnesses that are uncontrolled.

Active psychiatric illness/social situations that would limit compliance with protocol requirements.

New York Heart Association (NYHA) class II, class III, or IV congestive heart failure (any symptomatic heart failure).

Concurrent therapy with strong inhibitors of Cytochrome P450 3A4 or CYP2C8 due to concerning possible drug-drug interactions.

Concurrent therapy with strong inducers of Cytochrome P450 3A4 due to concerning possible drug-drug interactions.

Presence of concurrent medical conditions requiring systemic glucocorticoids for immunosuppression (e.g. autoimmune diseases, organ transplantation) that is active and has required glucocorticoids in the last 6 months.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT05726292) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Prostate Cancer Treatment Options in Chicago, IL

If you're searching for prostate cancer treatment options in Chicago, IL, this clinical trial (NCT05726292) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in Chicago, IL

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