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 diagnosed with metastatic castration-resistant prostate cancer (a form of prostate cancer that has spread and no longer responds to hormone-lowering treatment), confirmed by a lab test to be a specific type called adenocarcinoma, without certain aggressive features (called small-cell or neuroendocrine features).
• People who have previously been treated with at least one modern hormone-blocking drug, such as enzalutamide, apalutamide, darolutamide, or abiraterone.
• People who have had their testicles surgically removed or are currently receiving ongoing hormone-suppressing treatment, with testosterone levels confirmed to be very low (below 50 ng/dL or 1.7 nmol/L).
• People whose prior chemotherapy history with a drug type called taxanes meets the specific requirements of the group they are applying to join (confirm with trial site for which group applies).
• People in one specific group (Dose Expansion Group C only) who have previously received an approved course of a treatment called Lu-PSMA therapy, and did not stop that treatment due to side effects.
• People who are generally well enough to carry out light daily activities, rated 0 or 1 on a standard health performance scale (ECOG scale).
• People whose blood test results, taken within 30 days before starting the trial, show that their bone marrow, liver, and kidneys are functioning adequately — including specific levels of red blood cells, white blood cells, platelets, liver enzymes, and kidney function (confirm exact values with trial site).
• People who have at least one tumour lesion that shows up positively on a special type of scan called a PSMA PET/CT scan, meaning the lesion absorbs more of the scan tracer than the liver does.
• People whose cancer is confirmed to be getting worse, with a PSA level of at least 2.0 ng/mL, based on at least one of the following: rising PSA levels on two tests, new or growing tumours on imaging, or two or more new spots on a bone scan.

Who may not be able to join:

• People who have tumour lesions that do NOT show up on the PSMA PET/CT scan (meaning the lesion absorbs the same or less tracer than the liver) AND are above certain sizes — for example, lymph nodes 2.5 cm or larger, organ tumours (such as in the lung or liver) 1 cm or larger, or bone tumours with a soft tissue portion of 1 cm or larger that is also PSMA-negative.
• People who have had a mostly dead (necrotic) tumour lesion with more than 1 cm of active surrounding tissue visible on a contrast scan.
• People who received systemic cancer treatments — such as chemotherapy, hormone-blocking drugs, immunotherapy, or experimental therapies — within 4 weeks before starting the trial (a shorter gap may be considered depending on the specific drug; confirm with trial site).
• People who have previously received a radioactive treatment using a substance called actinium-225.
• People in the Dose Escalation or Dose Expansion Groups A and B who have previously received any radioactive cancer treatment, except for radium-223 dichloride taken more than 3 months before starting the trial — and only if they did not stop radium-223 due to side effects.
• People in Dose Expansion Group C who have previously received any radioactive cancer treatment other than radium-223 dichloride (more than 3 months prior) or Lu-PSMA therapy (more than 6 weeks prior), or who stopped either of those treatments due to side effects.
• People who completed major radiation therapy or surgery less than 6 weeks before starting the trial (limited palliative radiotherapy may be considered under certain conditions; confirm with trial site).
• People who are still experiencing significant side effects (grade 2 or higher on a standard toxicity scale) from previous cancer treatments that have not yet stabilised.

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