At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed prostatic adenocarcinoma without primary small cell histology
- ✓Localized disease with documented surgical resectability and no distant metastases (N1 regional nodes allowed)
- ✓High or very high-risk disease: Clinical T3a or higher, Grade Group 4-5, or PSA >20
- ✓Ability to understand and sign informed consent
- ✕Any prior hormonal therapy for prostate cancer (prior 5-alpha-reductase inhibitors for benign prostate allowed if discontinued)
- ✕Inability to swallow capsules or known gastrointestinal malabsorption
- ✕History of other malignancies except adequately treated non-melanoma skin cancer, superficial bladder cancer, stage 1-2 without disease, or >5 years disease-free from curative treatment
- ✕Uncontrolled blood pressure (SBP >160 and DBP >90 despite >2 oral agents)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Relacorilant, Enzalutamide, and 3 other interventions for Prostate Cancer and Prostate Adenocarcinoma. Currently recruiting, targeting 90 participants across 2 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Relacorilant is an antiglucocorticoid which is under development by Corcept Therapeutics for the treatment of Cushing's syndrome. It is being used in this study as an experimental drug combined with other treatments for prostate cancer.
Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen medication which is used in the treatment of prostate cancer.
This would be a sugar pill consisting of 2 softgels. This is not an experimental drug or treatment.
All participants in this study, who meet the requirements to participate, will get Androgen Deprivation Therapy (ADT; a form of hormone therapy) continuously before their radical prostatectomy surgery. As part of this study, ADT consists of one injection every 1-3 months. In this study, ADT is a gonadotropin releasing hormone (GnRH) agonists or antagonist; the choice of which brand of ADT to use is up to your treating physician. GnRH agonists and antagonists are drugs that lower the production of androgens (male hormones) in your body. Prostate cancer cells usually require androgens, such as testosterone, to grow. Androgen Deprivation Therapy (ADT) has been approved by United Stated Food and Drug Administration (US FDA) to treat patients with prostate cancer but is not approved to treat patients prior to prostatectomy.
Radical prostatectomy is surgery to remove the entire prostate gland and surrounding lymph nodes to treat men with localized prostate cancer.