Phase 2 Prostate Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who are able to give informed consent and are willing and able to attend scheduled medical visits and follow the study requirements.
• Men aged 18 years or older (up to 80 years old during the early dose-testing phase) at the time of signing the consent form.
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity (confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer) confirmed by laboratory testing of tissue or cells, and who have not been diagnosed with neuroendocrine or small cell carcinoma.
• People who are able to provide adequate blood samples for genetic testing during the screening period; providing tumour tissue samples is also recommended.
• Men whose partner could become pregnant must use highly effective contraception from the time of signing consent until 3 months after the last dose of the study drug.

Who may not be able to join:

• People who plan to receive any other cancer treatment during this study.
• People with a history of certain blood disorders (myelodysplastic syndrome or acute myeloid leukaemia), or who have had another type of cancer within the past 5 years.
• People currently taking part in another clinical trial, or whose last dose in a previous clinical trial was less than 4 weeks ago (or within a shorter timeframe based on the previous study drug's properties).
• People who have had major surgery within 28 days before the first dose, minor surgery within 7 days before the first dose, or who have wounds that have not healed or untreated broken bones.
• People who have recently taken certain medications that strongly affect how the body processes drugs (specifically strong CYP3A enzyme inducers or inhibitors), where not enough time has passed since stopping them (confirm with trial site).
• People whose side effects from previous cancer treatments have not improved to a mild level or resolved.
• People with known cancer spread to the brain or the lining around the brain, or who have a history of primary brain tumours.
• People who have had a serious stroke or other severe brain blood vessel event within the 6 months before starting the study.
• People with poorly controlled high blood pressure, or a history of hypertensive crisis or hypertensive encephalopathy (a serious complication of high blood pressure affecting the brain).
• People who have experienced serious bone damage from cancer spread to the bones, such as broken bones due to cancer or spinal cord compression, within the past 6 months or where this is expected to happen soon.
• People who have conditions or active gut diseases that could significantly affect how the body absorbs or processes oral medication.
• People with a known allergy to the study drug or any of its ingredients.
• People who have had active heart disease in the 6 months before the first dose, including severe chest pain, heart attack, significant heart failure, or certain heart rhythm problems.
• People with active hepatitis B or hepatitis C, or serious infections currently requiring antibiotic, antiviral, or antifungal treatment.
• People with a history of immune deficiency conditions or organ transplantation.
• People with other serious physical or mental health conditions or significant abnormal laboratory results.

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