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 aged 18 or older who are able to give written consent to participate
• People who have been confirmed through a tissue sample (biopsy) to have prostate cancer (certain subtypes with neuroendocrine features are allowed, but pure small cell carcinoma is not)
• People whose cancer has spread, shown by at least 2 bone lesions on a bone scan, or by soft tissue disease visible on a CT or MRI scan (spread seen only on PET scans does not count)
• People currently taking a full standard dose of either abiraterone acetate (1000 mg daily) or enzalutamide (160 mg daily), with that medication having been started at least 90 days before screening, and who are tolerating it well (people on a reduced dose or who cannot tolerate these medicines would not be eligible)
• People whose prostate cancer has continued to grow or spread despite taking abiraterone acetate or enzalutamide, shown by rising PSA levels, new or growing soft tissue disease, or new bone lesions (as measured by specific medical criteria)
• People who have either a measurable tumour or a PSA level of 2.0 ng/mL or above at the time of joining
• People whose testosterone has been suppressed through ongoing hormone-blocking therapy for at least 90 days, or who have had both testicles surgically removed
• People with a general health performance score of 0, 1, or 2 on a standard medical scale (meaning the person is fully active, or able to carry out light activity, or able to care for themselves but unable to do active work)
• People whose blood tests show the liver, kidneys, blood cells, and clotting function are within acceptable ranges at the time of screening
• People who are able to provide a tumour tissue sample from either a new biopsy or a recent previous biopsy (if safely possible); if neither is possible, older stored tissue may be requested if available

Who may not be able to join:

• People whose prostate cancer is classified as pure small cell carcinoma
• People who have previously been treated with therapies that target multiple cell-signalling pathways at once (multi-TKI therapies)
• People with uncontrolled high blood pressure (consistently 140/90 mmHg or above), or known coronary artery disease with chest pain (people with known high blood pressure may be eligible if it is well controlled on medication)
• People with a history of moderate-to-severe heart failure, certain serious heart rhythm problems requiring treatment, a heart attack within the past 6 months, or an abnormal heart electrical reading above a specific threshold at screening
• People with another cancer (past or current) that could interfere with the safety or results of this trial
• People with brain or spinal cord metastases that are causing symptoms or have not been treated
• People with a stent in the upper small intestine, or any digestive condition that could prevent the study medication from being properly absorbed
• People who have needed ongoing steroid medication (such as prednisone) at a dose above 10 mg daily within the 14 days before starting the study treatment
• People who have received other cancer treatments within 3 weeks before starting the study (or within a shorter timeframe for certain oral medicines), not including hormone-blocking therapy, enzalutamide, or abiraterone acetate, which should be continued
• People who have received radiation treatment for pain relief within 2 weeks before starting the study treatment

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