Trial comparing treatments 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?
an investigational oral drug being studied as a potential treatment for advanced, high‑risk prostate cancer is designed to block glucocorticoid receptors, reducing the effect of cortisol in the body
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
- This study is testing whether the combination of relacorilant and enzalutamide, along with hormone therapy, is safe and works for people with high‑risk prostate cancer.
- Who it's for
- You may be able to join if you have high‑risk prostate cancer and other treatments have not worked well for you.
- What's involved
- You would take the study drugs and hormone therapy at home and have regular check‑ups at the clinic to monitor your health and any side effects.
- Time commitment
- The study lasts about 3 years and 9 months, with visits and tests scheduled throughout that time.
- 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
- 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
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
- 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
- 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
- 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
- Platelet count (plt) 100,000 /L
- Hemoglobin (Hgb) 10 g/dL
- Absolute neutrophil count (ANC) 1500
- 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...
- Condom (barrier method of contraception) AND
- 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 is enrolling
- Chicago, Illinois, United States
- Portland, Oregon, 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, but 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?
This study is enrolling now at Chicago, Illinois, United States; Portland, Oregon, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.