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:

• People who are relatively well and able to carry out daily activities, rated 0 or 1 on a standard health performance scale used in cancer care.
• People who have been diagnosed with a specific type of prostate cancer called adenocarcinoma, confirmed by laboratory testing, and without strong signs of a particular subtype called neuroendocrine differentiation.
• People who have had both testicles surgically removed and/or are receiving ongoing hormone-suppressing therapy, with testosterone levels in blood kept very low (below 50 ng/dL or 1.7 nmol/L).
• People who have at least one area of cancer spread (metastasis) visible on a CT scan, MRI, or bone scan taken within 28 days before starting the trial treatment.
• People whose kidneys, liver, and other organs are functioning at an adequate level.
• For Part A only: People with prostate cancer that has spread and is no longer responding to hormone therapy (known as metastatic castration-resistant prostate cancer, or mCRPC), whether it appears stable or is getting worse.
• For Part B only: People with mCRPC that is getting worse, shown by rising PSA levels in the blood, growth of soft-tissue tumours, or worsening bone disease.
• For Part B Dose Escalation only: People who have already received at least 2 previous systemic cancer treatments for mCRPC, including at least one hormone-blocking drug (ARPI), and — if relevant — a PARP inhibitor (for those with a BRCA gene mutation) and/or an immunotherapy checkpoint inhibitor (for those with certain tumour characteristics).
• For Part B Dose Expansion only: People who have already received at least 1 previous systemic cancer treatment for mCRPC, including at least one hormone-blocking drug (ARPI), and — if applicable — a PARP inhibitor and/or a checkpoint inhibitor based on tumour characteristics; prior chemotherapy for mCRPC is not allowed, though certain chemotherapy (taxanes) given more than 12 months earlier for an earlier stage of the disease may be acceptable (confirm with trial site).
• For Part B Dose Expansion only: People who have or have not previously received a type of targeted radiation treatment called PSMA radioligand therapy or Radium-223 — prior radiation treatments of various kinds are generally permitted if all other criteria are met.

Who may not be able to join:

• People who have received any radioactive drug treatment within 6 weeks before the first trial treatment dose.
• People who have had radiation therapy within 28 days before the first dose, or whose side effects from radiation have not yet recovered to a mild level.
• People who have received any systemic cancer treatment or experimental therapy within 28 days (or a shorter timeframe depending on the specific drug) before the first trial dose.
• People who still have significant side effects from previous cancer treatments that have not yet recovered to a mild level.
• People with serious ongoing illnesses unrelated to cancer, or personal or social circumstances that would make it difficult to follow the trial's requirements.
• People with known or suspected allergies or medical reasons that prevent them from receiving the trial drugs or their ingredients.
• People with a clinically significant level of protein in their urine.
• People whose bone scans or PSMA imaging show a very widespread pattern of cancer throughout the skeleton, known as a "superscan."
• People taking high daily doses of steroid medications (more than 10 mg of prednisone or its equivalent per day on an ongoing basis).

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