Phase 1 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:

• People who have been confirmed through lab testing (tissue or cell samples) to have prostate cancer of the adenocarcinoma type — mixed types (such as adenocarcinoma combined with a neuroendocrine component) are not permitted.
• People who were diagnosed with prostate cancer that had already spread to other parts of the body at the time of first diagnosis (with no prior diagnosis of localised prostate cancer), known as de novo metastatic hormone-sensitive prostate cancer.
• People who have started hormone-blocking treatment (called ADT, which may include injections, implants, or surgical removal of the testicles), with or without certain additional cancer medicines (abiraterone or darolutamide), and whose first ADT treatment began no more than 12 weeks before the trial screening visit.
• People whose cancer has spread widely — specifically, those with cancer that has spread to internal organs, and/or four or more bone sites with at least one bone site outside the spine and pelvis.
• People whose spread of cancer has been confirmed by a bone scan, CT scan, or MRI scan.
• People whose PSA levels have not shown a documented rise after reaching their lowest point following the start of hormone-blocking treatment.

Who may not be able to join:

• People with a history of cancer that has spread to the brain or spinal cord — although people with stable, symptom-free spread to the lining around the brain (dura) may still be considered (confirm with trial site).
• People who still have unresolved side effects from previous cancer treatments (not counting ongoing hormone therapy or abiraterone/darolutamide) that have not settled to a mild or baseline level, unless the side effects are stable, well-managed, and both the trial doctor and trial sponsor agree to allow participation.
• People who have had an autoimmune disease requiring whole-body immune-suppressing medicines within the past two years.
• People showing signs of an active, uncontrolled infection within the seven days before the first trial treatment dose.
• People who have previously received any therapy specifically targeting a protein called STEAP1.
• People who have previously received radioligand therapy, PARP inhibitors, chemotherapy, certain older hormone medicines (aminoglutethimide or ketoconazole), or any other systemic biological or immunotherapy for prostate cancer.
• People who have taken enzalutamide or apalutamide within 15 days before enrolling in the trial.
• People who require ongoing high-dose steroid treatment (prednisone above 10 mg per day or equivalent) or other immune-suppressing medicines, unless these were stopped (with appropriate dose reduction) at least seven days before the first trial treatment dose.
• People who have had radiation treatment applied to every single site where their cancer has spread (radiation to some sites for pain relief is permitted).

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