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 have been diagnosed with prostate cancer (adenocarcinoma type) confirmed by a tissue or cell sample
• People whose prostate cancer has spread to other parts of the body (metastatic) and is continuing to grow despite hormone-lowering treatment, shown by rising PSA levels, new or growing tumors in soft tissue, or new spots on bone
• People with a general health status rated as fully active, restricted in strenuous activity, or capable of self-care but unable to work (confirm with trial site for exact fitness level required)
• People whose testosterone blood levels are very low (below 50 ng/dL), either because they have had surgery to remove both testicles or because they are receiving ongoing hormone-suppressing injections or implants
• People who have previously been treated with at least one hormone-blocking drug, such as enzalutamide or abiraterone acetate
• People who have previously received a type of chemotherapy called taxane, were told by their doctor they were not suitable for it, or chose not to have it
• People aged 18 or older
• People whose blood test results show that the bone marrow, kidneys, and liver are functioning within the levels required by the trial (confirm with trial site for specific numbers)
• People who are able to understand the study information and are willing to sign a consent form

Who may not be able to join:

• People who have had an investigational medical device implanted within 4 weeks before the first treatment visit, or who are currently enrolled in another clinical trial involving a cancer drug or device
• People who have taken an experimental drug within 4 weeks (or within 5 half-lives of the drug, whichever is longer) before the first treatment visit, or who are currently in another cancer drug or device trial
• People who have previously received a type of radioactive bone treatment that emits beta radiation — though prior radium-223 treatment may be allowed if at least 90 days have passed since the last dose
• For people entering the group with no prior PSMA-targeted radiation treatment: prior use of PSMA-targeted radiation therapy for treatment is not allowed (PSMA scans used for diagnosis are acceptable, as is PSMA-targeted therapy that did not involve radioactive treatment); for people entering the group who have had prior lutetium-177 PSMA treatment: no severe treatment-limiting side effects must have occurred during or after that prior treatment
• People who have active cancer that has spread to the brain or the lining surrounding the brain and spinal cord
• People who have had a blood clot in a vein or in the lungs within 1 month before the first treatment visit
• People with serious illnesses affecting the heart, lungs, brain or nervous system, kidneys, liver, or blood, which could prevent completion of the study or make it hard to assess side effects
• People who have had radiation therapy for prostate cancer within 4 weeks before the first treatment visit
• People who are not already taking bone-protecting medications (bisphosphonates or denosumab) are not permitted to start these medications during the early safety-monitoring period of the study (those already on a stable dose for at least 4 weeks before starting the trial may continue)
• People who have a partner who could become pregnant and who are not willing to use an acceptable form of contraception during the study and for at least 140 days after the last dose of the study drug
• People who currently have another active cancer, other than certain common skin cancers — a cancer may be considered inactive if treatment is complete and a doctor considers the chance of it returning to be less than 30%
• People with a known history of a bone marrow disorder called myelodysplastic syndrome
• People whose bone scan shows a pattern of very widespread bone involvement (called a "superscan"), as determined by the study doctor
• People who have previously been treated with a type of drug called a PARP inhibitor for more than 2 weeks

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