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 at the time of giving consent to participate.
• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed through laboratory testing of tissue or cell samples, including cases with small cell or neuroendocrine features.
• People whose prostate cancer has continued to grow or spread despite having testosterone reduced to very low levels through surgery or ongoing medication (a condition known as castration-resistant prostate cancer).
• People whose cancer has continued to progress, shown by rising PSA levels (measured at least one week apart, with PSA above 1 ng/mL) or by changes visible on scans.
• People whose cancer shows up as PSMA-positive on a specific type of scan called a PSMA-PET-CT scan done during screening.
• People who have previously been treated with at least one newer type of hormone-blocking medication for prostate cancer (called a second-generation androgen receptor pathway inhibitor).
• People who have previously received one or two rounds of taxane chemotherapy for prostate cancer, or whose treating doctor has determined they are not suitable for, or who have declined, taxane therapy.
• People for whom at least four weeks (or five half-lives of the drug, whichever is longer) have passed since their last cancer treatment, not counting hormone-suppressing therapy, which should continue. Low-dose prednisone (up to 10 mg daily or equivalent) is also permitted during this period.
• People who have previously received up to six cycles of a specific radioactive treatment called 177Lu-PSMA (such as 177Lu-PSMA-617 or 177Lu-PSMA-I&T) and whose treating doctor judged that they responded to it, with the last dose given more than 10 weeks before joining the trial. (In Phase I only, the first three participants treated at each dose level may not have had prior 177Lu-PSMA treatment.)
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (ECOG performance status), meaning they are fully active or able to carry out light activity.
• People with an estimated life expectancy of more than 12 weeks.
• People with no more than mild dry mouth symptoms at the time of joining the trial.
• People with adequate bone marrow, kidney, and liver function based on blood test results (confirm with trial site for specific thresholds).
• People whose side effects from previous treatments have mostly resolved, with only mild (Grade 1 or lower) effects remaining — with some exceptions allowed for certain types of nerve-related side effects, urinary frequency, and hair loss from chemotherapy.
• People who are willing and able to use adequate contraception, for themselves and their partners, as required by the trial.
• People who are willing and able to give written informed consent to participate.

Who may not be able to join:

• People who have symptoms of spinal cord compression, or whose scans suggest the spinal cord is at risk of being compressed.
• People who have active cancer that has spread to the brain or the lining around the brain or spinal cord.
• People who have received 177Lu-PSMA treatment within the 10 weeks before joining the trial.
• People who have previously received other radioactive treatments for cancer that has spread (such as Radium-223), though prior radioactive treatment for other types of cancer (such as radioactive iodine for thyroid cancer) is permitted.
• People who have received blood transfusions or red blood cell-stimulating injections within four weeks before joining the trial.
• People who have had major surgery within 12 weeks before joining the trial.
• People who currently have, or have been diagnosed with or had a relapse of, another cancer within the past five years — with some exceptions for certain low-risk skin cancers and early-stage bladder cancer that has been treated with curative intent.
• People who have Sjögren's disease or any other condition that, in the trial doctor's judgement, significantly raises the risk of developing dry mouth.
• People with only one kidney, a transplanted kidney, or any kidney-related condition or medication that, in the trial doctor's judgement, could lead to an unacceptable risk of kidney damage during the trial.
• People with severe urinary incontinence or other conditions that, in the trial doctor's judgement, would make it unsafe to manage radioactive urine.
• People with structural problems affecting the kidneys or urinary tract that could affect how the trial treatment is processed by the body, unless the problem has been corrected through a procedure (confirm with trial site).
• People with significant abnormalities found on a heart tracing (ECG) done during the screening process.
• People with serious ongoing health conditions that, in the trial doctor's judgement, would make participation unsafe or difficult.
• People who have received radiation therapy within two weeks before joining the trial.
• People who are known to be allergic or hypersensitive to the trial treatment or any of its ingredients.
• People who are currently taking part in another clinical trial that involves receiving an experimental treatment.
• People whose personal, family, social, or geographic circumstances might make it difficult to follow the trial schedule or could pose a risk to their safety.

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