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Compares treatment options for Prostate Cancer
Official title A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
ClinicalTrials.gov ID: NCT05726292
What this study is testing
What is Relacorilant?
Relacorilant is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- Therapy with ANY hormonal therapy for prostate cancer (prior 5-alpha-reductase inhibitors for benign prostate disease is allowed but must be...
- 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...
- Blood pressure that is not controlled despite \> 2 oral agents (SBP \>160 and DBP \>90 documented during the screening period with no subsequent...
- 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.
See the full eligibility 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
- 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 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...
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.