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:

• A tissue sample (biopsy) has confirmed a diagnosis of prostate adenocarcinoma (a specific type of prostate cancer).
• The cancer is detectable either through standard imaging measurements or through bone-only spread with a PSA blood level of at least 1 ng/mL.
• The cancer has continued to grow or spread after becoming "castration-resistant" (meaning it kept progressing even when testosterone was suppressed), shown by rising PSA levels, new tumour growth on scans, or new bone lesions.
• At least two separate lines of treatment for metastatic prostate cancer have been received, including at least two FDA-approved therapies, with at least one being a newer hormone-blocking drug such as abiraterone, darolutamide, apalutamide, or enzalutamide.
• All other targeted treatments for which the person was eligible (such as PARP inhibitors for BRCA 1/2 mutations, or immune checkpoint inhibitors for certain tumour types) have already been received.
• Testosterone levels are at castrate levels (below 50 ng/dL), with or without ongoing hormone-suppression therapy.
• The person is 18 years of age or older at the time of enrolment.
• The person is able to understand the trial and provide written informed consent.
• Male participants who are able to father children, and their female partners, must be willing to use effective contraception before, during, and for at least 4 months after the cell infusion.
• General physical health is good enough to be up and about, with little or no restriction on daily activities (confirmed using a standard medical scale called ECOG 0 or 1).
• Palliative radiation therapy is permitted during the study, except in the two weeks before a blood cell collection procedure called leukapheresis.
• Kidney function is within an acceptable range, as measured by blood tests, and the person is not on dialysis (confirm with trial site).
• Liver function blood test results are within acceptable limits; people with a condition called Gilbert syndrome may still be considered if certain criteria are met (confirm with trial site).
• Two specific liver enzyme levels (AST and ALT) are below five times the normal upper limit.
• Breathing difficulty is minimal or absent, and blood oxygen levels are at least 92% on room air.
• If breathing tests are performed, lung function results must meet minimum thresholds set by the trial (confirm with trial site).
• People aged 60 or older must have had a heart function scan (echocardiogram or MUGA) within the past year showing the heart is pumping at least 35% of its capacity; heart assessment for younger participants is decided by the treating doctor.
• Blood cell counts (white cells, red cells, and platelets) are all within the minimum levels required by the trial (confirm with trial site for exact values).

Who may not be able to join:

• People who are planning to father children during the trial or within 4 months after the cell infusion.
• People with an active autoimmune disease that currently requires immune-suppressing medication (exceptions may be considered by the lead trial doctor on a case-by-case basis).
• People taking corticosteroid medication (such as prednisone) at a dose higher than 15 mg per day on an ongoing basis; short-term higher doses for disease control may be acceptable.
• People currently taking any other experimental anti-cancer treatments, aside from hormone-suppression therapy.
• People with an active, uncontrolled infection (note: HIV that is well controlled on treatment with a CD4 count above 500, previously treated hepatitis C with an undetectable viral load, and well-controlled hepatitis B on medication are generally considered acceptable).
• People with serious uncontrolled health conditions such as severe heart failure, unstable chest pain, or uncontrolled heart rhythm problems that would make it difficult to participate safely.
• People with untreated brain metastases (spread of cancer to the brain); however, people with small, symptom-free brain metastases under 1 cm, or those whose brain metastases have been successfully treated with surgery or radiotherapy, may be considered at the lead doctor's discretion.
• People still receiving treatment for a serious immune-related side effect from a previous immunotherapy, with limited exceptions as approved by the lead trial doctor.
• People with significant active neurological (brain or nerve) disease, unless approved by the lead trial doctor; nerve damage from diabetes or past chemotherapy is generally acceptable.
• People with other medical, social, or personal circumstances that the lead trial doctor determines would make participation unsafe or not appropriate.
• People with a known allergy to any component of the study treatments.

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