Phase 2 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:

• You have prostate cancer that has spread (metastatic) and shows signs of a specific type called neuroendocrine prostate cancer, confirmed by biopsy, blood tests, or certain molecular features
• You are 18 years of age or older (there is no upper age limit)
• You are well enough to carry out everyday activities, with only mild limitations at most (your doctor can assess this)
• Your blood counts are at safe levels — including white blood cells, platelets, and hemoglobin — before each treatment dose
• Your liver and kidney function are within acceptable ranges based on blood tests
• If you have HIV, you are on effective treatment and your virus levels are undetectable within the last 6 months
• If you have or had hepatitis B, your virus levels are undetectable on treatment
• If you have had hepatitis C, you have been successfully treated and cured, or are currently on treatment with undetectable virus levels
• If you have had brain metastases (cancer spread to the brain), they have been treated and follow-up scans show no sign of worsening
• You have a heart health classification of 2B or better (confirm with trial site)
• Your cancer is currently getting worse based on specific monitoring guidelines (confirm with trial site)
• You are willing and able to use effective contraception during the study and for 4 months after finishing treatment, and agree not to donate sperm during the study and for 3 months after the last dose
• You are able to understand and sign a consent form, or have a legal representative who can do so on your behalf
• A special nuclear imaging scan (Gallium-68 Dotatate PET scan) done after enrollment shows at least one area of cancer that "lights up" above a certain level — this must be positive to proceed with treatment

Who may not be able to join:

• You are currently taking part in another clinical trial involving an experimental treatment
• You have had a serious allergic reaction to a drug similar to the study treatment (Lutetium Lu 177 dotatate)
• You are currently taking certain hormone-blocking medications called somatostatin analogs (long-acting ones within the last 4 weeks, or short-acting ones within the last 24 hours), unless you need them for a specific condition called carcinoid syndrome
• You have another serious illness that is not well controlled
• You have had a stroke, heart attack, severe chest pain, bypass surgery, or serious heart failure within the 6 months before starting the trial
• Your blood pressure is too high at the time of screening (top number 160 or above, or bottom number 100 or above)

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