Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• A diagnosis of prostate cancer (adenocarcinoma type) confirmed by a tissue or cell sample, without a small cell type.
• The cancer must be localised (contained to the prostate area), with a surgeon confirming it can be removed by surgery before joining.
• No signs of cancer that has spread to distant parts of the body on imaging scans (some nearby enlarged lymph nodes are still allowed).
• The cancer must be classified as high or very high risk, meaning at least one of: the tumour has grown beyond the prostate (clinical stage T3a or higher), a high-grade score on biopsy (Grade Group 4 or 5), or a PSA level above 20.
• A general health and activity level rated at 0 or 1 on a standard scale, meaning fully active or able to carry out light work (confirm with trial site).
• A total testosterone level of at least 100 ng/dL in the blood.
• Liver function blood test results within acceptable ranges as defined by the trial (confirm with trial site).
• Bone marrow function blood test results within acceptable ranges, including platelet count, haemoglobin, and white blood cell count (confirm with trial site).
• Kidney function showing a filtration rate of at least 30 mL/min.
• Willingness and ability to read and sign a written consent form.
• People with active diabetes managed by glucose-lowering medication may be considered eligible, provided daily self-monitoring of blood sugar levels is possible and agreed to.
• Male participants with a female partner who could become pregnant must agree to use two forms of contraception — including a condom — from the start of the trial until three months after the last dose of study medication.

Who may not be able to join:

• Anyone who has already received hormonal therapy for prostate cancer (prior use of 5-alpha-reductase inhibitors for a non-cancerous prostate condition is allowed, but must be stopped before starting the trial).
• Anyone unable to swallow capsules, or who has a condition affecting absorption of medication in the gut.
• Anyone with a history of another cancer, unless it was an early-stage or non-melanoma skin cancer that was successfully treated, or any other cancer with no signs of disease for more than five years before joining.
• Anyone with blood pressure that remains uncontrolled despite taking more than two blood pressure medications (confirm with trial site for specific thresholds).
• Anyone with a history of seizures, or currently taking anti-seizure medications (medications for nerve pain such as gabapentin or pregabalin are allowed).
• Anyone with a serious ongoing infection or uncontrolled non-cancer medical illness.
• Anyone with active psychiatric conditions or personal circumstances that would make it difficult to follow the trial requirements.
• Anyone with symptomatic heart failure (any level that causes symptoms).
• Anyone currently taking certain medications that strongly affect how the body processes a group of liver enzymes (CYP3A4 or CYP2C8), due to possible interactions with the trial drug (confirm current medications with trial site).
• Anyone currently taking certain medications that strongly activate the same liver enzyme pathway (CYP3A4), also due to possible drug interactions (confirm with trial site).
• Anyone who has needed long-term steroid (glucocorticoid) medication in the last six months to manage an immune condition or following an organ transplant.

Important: Always verify eligibility with the trial site directly before applying.