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 given written consent to take part (or whose legal representative has done so on their behalf)
• People who agree to allow stored tumour tissue from a previous biopsy to be used for the study (exceptions may be possible with approval from the study's lead doctor)
• People aged 18 or older
• People who are male
• People whose general health and ability to carry out daily activities meets a specific standard — scored 0 or 1 on a scale used by doctors to measure this (confirm with trial site)
• People who have prostate cancer that has spread to other parts of the body, has continued to grow despite hormone-lowering treatment, and has been confirmed by a pathologist as a specific type called adenocarcinoma (without small cell features)
• People whose cancer can be measured on scans, or whose cancer is present but too small or in areas (such as bone only) that cannot be directly measured
• People who have been on treatment to reduce testosterone levels — either through medication or surgery — for at least 3 months before joining, with testosterone blood levels remaining below a set threshold throughout the trial
• People who have recovered from most side effects of any previous cancer treatment before starting the trial
• People whose recent blood test results (taken within 10 days before starting treatment) meet specific healthy ranges for immune cells, platelets, and red blood cells
• People whose recent liver function blood test results fall within acceptable ranges
• People whose recent kidney function results fall within acceptable ranges
• People whose recent blood clotting test results fall within acceptable ranges (different standards apply depending on whether the person is on blood-thinning medication)
• People who have tested negative for HIV, Hepatitis C, active Hepatitis B, and syphilis on recent blood tests — or, if any result is positive, whose viral levels are undetectable on further testing
• People who meet the trial site's infectious disease testing requirements
• People (and their partners, if their partner could become pregnant) who agree to use highly effective contraception or abstain from sexual activity during the study and for at least 4 months after the last dose of treatment

Who may not be able to join:

• People who have received any approved or experimental cancer treatment — including chemotherapy, hormone therapy, or radiation — within 4 weeks before starting the trial
• People who have had any of the following within 28 days of registering: external beam radiation or surgery; certain herbal supplements including PC-SPES or saw palmetto; systemic (whole-body) steroid medications; specific hormone-related medications including megestrol acetate, diethylstilbestrol, cyproterone acetate, or ketoconazole; certain medications that affect male hormones (such as finasteride or dutasteride); or high-dose Vitamin D
• People who have previously been treated with a specific targeted radiation therapy (¹⁷⁷Lu-PSMA-617) or a specific immunotherapy (sipuleucel-T)
• People who have had radiation to bone spread within 2 weeks, or any other radiation within 4 weeks, before the first dose
• People with known significant liver disease, including active hepatitis, cirrhosis, fatty liver disease, or inherited liver conditions
• People who have received an experimental vaccine within the past 2 years, or any other experimental treatment within 28 days of registering
• People with certain types of blood cancers, including acute leukaemia, certain forms of chronic leukaemia, Burkitt lymphoma, plasma cell leukaemia, or non-secretory myeloma
• People with a known cancer originating in the brain or spinal cord, or with symptoms caused by cancer that has spread there
• People who are unable to follow the study procedures and follow-up requirements
• People who have, or have been diagnosed within the past 3 years with, another cancer that requires active treatment — with some exceptions for certain skin cancers or early-stage cancers that appear to have been fully treated
• People with any other health condition that the study doctor believes would make participation unsafe
• People who, in the study doctor's opinion, may not be able to follow all study procedures for practical or logistical reasons

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