TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to no maximum
- SexMale
- Healthy volunteersNo
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
- 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.
- 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.