Phase 1 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:

• Men aged 18 or older at the time of signing the consent form (or older if local laws require a higher age of consent for trial participation).
• People with a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer confirmed through tissue testing), including cases with some neuroendocrine features, but not pure small cell carcinoma.
• People whose prostate cancer has shown signs of getting worse, based on specific standardised measurement criteria used in cancer research.
• People whose cancer has spread to other parts of the body, confirmed by imaging scans such as CT, MRI, or bone scan.
• People who are currently receiving treatment to lower androgen (male hormone) levels, with that treatment having started at least 4 weeks before joining and continuing throughout the trial.
• People with a baseline PSA level of 2 ng/mL or higher, recorded in a documented test result.
• People who have previously been treated with a type of medication known as an Androgen Receptor Pathway Inhibitor (a drug that blocks male hormones from fuelling cancer growth).
• People with a general health and activity level rated as 0 or 1 on a standard scale used in cancer trials (meaning fully active or able to carry out light activity), assessed within 28 days before joining.
• People who are able and willing to provide a tumour tissue sample — either a newly obtained biopsy before treatment starts, or a stored sample from a tumour that was not previously treated with radiation and was collected after the most recent prior treatment, if a new biopsy is not safely possible.
• People who are capable of producing sperm and agree to follow specific contraception requirements for the duration of the trial and for at least 3 months after the last dose, including not donating or freezing sperm during this period (confirm with trial site for full details).

Who may not be able to join:

• People who have previously been treated with certain epigenetic therapies, including drugs that target EZH1, EZH2, EZH1/2, or PRC2 (a group of proteins involved in gene regulation).
• People whose baseline bone scan shows a specific pattern called a "super scan," where the bones show very intense activity in a way that would make it difficult to detect new spread in the future.
• People with active or symptomatic cancer that has spread to the brain, compressed the spinal cord, or spread to the lining around the brain and spinal cord, particularly if it requires treatment with steroids or anti-seizure medications.
• People with uncontrolled or significant heart or blood vessel disease.
• People who have had another cancer that was active within the past 3 years, unless it was a type considered easily treatable and apparently cured, such as certain skin cancers, early-stage bladder cancer, or non-invasive cancers of the stomach or breast lining.
• People with an active or uncontrolled Hepatitis B (HBV) infection.
• People with an active or uncontrolled Hepatitis C (HCV) infection.
• People with an active or uncontrolled HIV infection.

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