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:

• People who have been diagnosed with prostate cancer (specifically adenocarcinoma) confirmed by a laboratory tissue or cell test, without certain aggressive subtypes called small-cell or neuroendocrine features
• People whose prostate cancer has spread to other parts of the body (metastatic), is no longer responding to hormone therapy (castration-resistant), and is getting worse — shown by rising PSA levels measured at least three times over separate days, by growth of soft tissue tumours measured by standard imaging criteria, or by two or more new bone spots found on a bone scan
• People who have previously received exactly one treatment from a specific group of hormone-blocking drugs (abiraterone, apalutamide, enzalutamide, or darolutamide), whether that was given for hormone-sensitive or castration-resistant prostate cancer
• People who are able to provide a tumour tissue sample of adequate quality and quantity for biomarker testing
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site)
• People whose fasting blood sugar is below 100 mg/dL and whose HbA1c (a measure of average blood sugar over time) is below 5.7%, indicating no signs of diabetes or pre-diabetes

Who may not be able to join:

• People whose cancer has spread to the liver
• People who have previously been treated with a drug that works by blocking a specific cell signalling pathway known as PI3K/AKT/mTOR (confirm with trial site for specific drug names)
• People who have been diagnosed with Type 1 or Type 2 diabetes
• People who have received certain prior treatments for advanced castration-resistant prostate cancer, including chemotherapy or newer hormone-blocking drugs — though some prior treatments may still be permitted under specific conditions, such as docetaxel given in earlier disease settings, sipuleucel-T (if the last dose was more than 28 days before the start of the trial), certain PARP inhibitor therapy (if the last dose was more than 14 days before), or one prior radioligand or radiotherapy treatment such as PSMA-targeted therapy or Radium-223 (if the last dose was more than 8 weeks before) — confirm all prior treatment history with the trial site
• People who are currently receiving any other cancer treatment, apart from androgen deprivation therapy (a standard hormone-lowering treatment for prostate cancer)
• People who have taken certain medications that strongly affect how the body processes drugs (specifically strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers) within one week or five drug half-lives before starting the trial, whichever period is longer (confirm with trial site)
• People who have received a blood transfusion within 28 days of enrolling, or where a transfusion was given specifically to make someone appear eligible for the trial

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