Phase 1 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:

• People diagnosed with prostate cancer that has stopped responding to hormone therapy (castration-resistant prostate cancer) and is getting worse, shown either by rising PSA levels (at least 2 ng/mL, measured three times at least one week apart, with two readings more than 50% above the lowest recorded level) or by tumour growth or new lesions seen on scans.
• People whose testosterone levels in the blood remain at a very low "castration level" (below 50 ng/dL).
• People who have already tried at least one hormone-blocking treatment, such as enzalutamide, apalutamide, or abiraterone acetate, and whose cancer continued to progress.
• People who have previously received taxane-based chemotherapy (such as docetaxel or cabazitaxel), or for whom that type of chemotherapy was not suitable or was declined.
• People aged 18 or older at the time of giving consent to join the trial.
• People who are in reasonably good general health, rated 0 to 2 on a standard medical scale used to measure how much a person's illness affects their daily activities (ECOG Performance Status).
• People who, based on their current health, are expected to survive for at least 6 months.
• People who have no brain metastases, or whose brain metastases are present but are currently stable and well controlled.
• People with no significant problems found in a recent heart tracing (ECG), breathing rate, or blood oxygen levels, checked within 30 days before joining.
• People whose recent blood test results (within 30 days before joining) fall within the ranges required by the trial protocol.
• People who are able and willing to use appropriate contraception throughout the trial period, as set out in the trial protocol.
• People who have been fully informed about the trial, agree to all study procedures, and have signed a consent form.

Who may not be able to join:

• People who received systemic anti-cancer treatments — such as chemotherapy, immunotherapy, or treatments using monoclonal antibodies — within 4 weeks before enrolling (hormone-blocking treatments are excluded from this restriction).
• People who received radium-223 (Radium chloride) or Lutetium-177 PSMA-617 therapy within the 6 months before registering.
• People currently receiving cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitors, or AKT inhibitors.
• People who have, or have recently had, a second separate cancer (either at the same time or within the past 5 years).
• People who took part in another clinical trial and received an experimental drug within 5 weeks before enrolling.
• People with an active infection that is not able to be controlled.
• People who test positive for Hepatitis B surface antigen, Hepatitis C virus antibody (unless the virus is undetectable in the blood), or HIV antibody.
• People with a mental illness or psychiatric symptoms that the trial team judges would make it difficult to safely participate.
• People who the trial investigator considers unsuitable for any other reason.

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