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 signed a written consent form agreeing to take part in the study
• Adults aged 18 or older
• People who have prostate cancer that has spread to other parts of the body and is no longer responding to hormone-lowering treatments (known as metastatic castrate-resistant prostate cancer)
• People whose testosterone levels are very low (below 50 ng/dL), whether or not they are currently on hormone-suppressing therapy
• People who have already received at least one standard treatment for their advanced prostate cancer, including at least one newer hormone-blocking drug (such as enzalutamide, apalutamide, darolutamide, or abiraterone) or a chemotherapy regimen containing a taxane drug (such as docetaxel or cabazitaxel)
• People whose kidneys, liver, and heart are functioning well enough, as confirmed by blood and heart tests done within 4 weeks of a doctor reviewing eligibility (confirm with trial site for specific test thresholds)
• People who are not on dialysis and have kidneys working above a certain level (confirm with trial site)
• People whose liver enzyme levels and bilirubin levels fall within acceptable ranges — a slightly higher bilirubin level may be acceptable for people with a condition called Gilbert's syndrome (confirm with trial site)
• People whose heart is pumping effectively, confirmed by an ultrasound of the heart showing at least 45% function
• People who have only mild or no shortness of breath, and whose blood oxygen level is above 92% while breathing normal room air
• People whose blood cell counts are at an acceptable level within 4 weeks of eligibility review, and who do not need regular blood transfusions to keep those levels up (confirm with trial site for specific thresholds)
• People who have a good general level of physical functioning, rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People who have not had their testicles surgically removed and who are able to continue hormone-suppressing injections or implants throughout the study
• People who are capable of having children and who agree to use an acceptable form of contraception as outlined in the study rules

Who may not be able to join:

• People with an active hepatitis B or hepatitis C infection
• People with any other active infection that is not under control
• People with significant heart failure classified as Class III or IV by a standard medical heart rating system, meaning people who have noticeable symptoms during minimal activity or at rest
• People with serious ongoing health conditions that a doctor determines would make participation unsafe
• People who have had another invasive cancer (other than the prostate cancer being studied) within the past 2 years — note that certain non-invasive skin cancers treated with the aim of a cure may still be considered eligible (confirm with trial site)
• People who need ongoing high-dose oral or injected steroid or immune-suppressing medications — low-dose steroids (equivalent to 10 mg or less of prednisone per day), skin creams containing steroids, and inhaled steroids are generally acceptable (confirm with trial site)
• People who have previously received a type of treatment that uses their own immune T-cells, unless that treatment was sipuleucel-T (a specific prostate cancer vaccine)
• People who have previously had a stem cell transplant using cells from another person
• People with an active autoimmune disease that requires ongoing treatment with immune-suppressing medication at a level equivalent to 10 mg or more of prednisone per day — people with autoimmune diseases affecting the nervous system, such as multiple sclerosis, will not be eligible
• People who have had an allergic reaction or sensitivity to any of the ingredients used in the study treatment, specifically human serum albumin, DMSO, or Dextran 40

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