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:

• The patient has signed a consent form to take part in the trial
• The patient is male and over 18 years of age
• The patient has prostate cancer that has spread and no longer responds to hormone treatment (mCRPC), tests positive for PSMA, and has already received both a hormone-blocking drug and chemotherapy — or is considered medically unfit for chemotherapy
• The patient is already receiving standard treatment with a radioactive drug called 177Lu-PSMA-I&T and has completed at least the first two treatment cycles
• Scans show at least 3 tumours larger than 1.5 cm that show a strong uptake of PSMA on a specialised PET/CT scan
• The patient is in good general health, able to carry out daily activities with little to no limitation (confirm with trial site for exact scoring)
• Blood test results meet minimum levels for white blood cells, haemoglobin (red blood cell measure), and platelets
• Kidney function is above a minimum level, as measured by a standard blood test
• Blood protein (albumin) levels are above a minimum level
• Liver-related blood test results are within an acceptable range
• Male patients who have not had a surgical procedure to prevent fertility must use appropriate contraception during treatment and for 4 months after treatment ends — acceptable methods include sexual abstinence or a combination of hormonal contraception and a barrier method

Who may not be able to join:

• The patient has previously received PSMA-targeted radioactive therapy, other than the first two cycles that are part of this trial
• The patient's cancer does not show positive PSMA results on scans, or shows a pattern suggesting PSMA-negative disease
• The patient has a known allergy or intolerance to any of the components used in the trial treatments
• The patient has an active infection at the time of screening, or had a serious infection in the 4 weeks before joining
• The patient has taken part in another clinical trial and received an experimental treatment within the 60 days before the first study visit
• The patient has received, or is planned to receive, another therapeutic radioactive drug within a specific time window related to that drug's radioactive decay (confirm with trial site for exact timing)
• The patient has had extensive radiotherapy to areas involving bone marrow within the 3 months before joining
• The patient received chemotherapy within the 4 weeks before joining
• The patient has another serious uncontrolled medical, psychiatric, or surgical condition that could affect their safety or ability to take part — such as unstable heart conditions, poorly controlled blood pressure or diabetes, or a mental health condition that prevents understanding the study
• The patient has had another type of cancer (other than prostate cancer) within the past 5 years, except for certain fully removed skin cancers

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