A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ PSA \>20

• 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.

Locations
United States
Illinois
University of Chicago Comprehensive Cancer Center
RECRUITING
Chicago
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Cancer Trials
cancerclinicaltrials@bsd.uchicago.edu
1-855-702-8222
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 90
Treatments
Experimental: Group 1: Participants Who Receive Study Drug (Relacorilant) with Hormone Therapy and Enzalutamide
All participants in this group will have surgery up to 4 weeks after receiving enzalutamide/relacorilant with hormone therapy. A radical prostatectomy (removal of the prostate and any surrounding tissue that the surgeon thinks may be affected by the cancer).
Experimental: Group 1: Participants Who Receive Placebo (no study drug) with Hormone Therapy and Enzalutamide
All participants in this group will have surgery up to 4 weeks after receiving enzalutamide/placebo (sugar pill in the form of 2 softgel capsules) with hormone therapy. A radical prostatectomy (removal of the prostate and any surrounding tissue that the surgeon thinks may be affected by the cancer).
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov