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 are willing and able to give written consent before any study procedures begin.
• People whose prostate cancer meets the US FDA-approved criteria for a treatment called Sipuleucel-T — meaning the cancer causes no symptoms or only mild symptoms, as determined by the treating doctor.
• People whose prostate cancer has been confirmed by laboratory testing (biopsy) to be a specific type called adenocarcinoma.
• People whose prostate cancer has spread to other parts of the body (such as bones or soft tissue), as seen on imaging scans.
• People whose prostate cancer has continued to grow or spread despite hormone-lowering treatment (castration), shown by rising PSA levels, growth of measurable tumours, or the appearance of new lesions or bone spots on imaging.
• People whose testosterone level in the blood is below 50 ng/dL, confirming that hormone-lowering treatment is active.
• People who are generally well enough to carry out daily activities, rated as 0 or 1 on a standard medical scale (ECOG), meaning fully active or restricted in strenuous activity only.
• People whose liver is functioning adequately, based on specific blood test results within acceptable ranges.
• People whose kidneys are functioning adequately, based on a specific blood test result within an acceptable range.
• People whose blood counts (white blood cells, platelets, and red blood cells) are within acceptable ranges.

Who may not be able to join:

• People whose PSA level was above 20 ng/dL in the 4 weeks before signing the consent form.
• People who have previously been treated with three or more FDA-approved hormonal drugs that block androgen or androgen receptor signalling (such as abiraterone, enzalutamide, apalutamide, or darolutamide).
• People who have previously received chemotherapy specifically for castration-resistant prostate cancer (confirm with trial site for details about earlier-stage chemotherapy history).
• People who have previously been treated with Sipuleucel-T, or with high-dose testosterone as a prostate cancer treatment.
• People who have received certain systemic prostate cancer treatments — including hormonal drugs, PARP inhibitors, Radium-223, or other anti-cancer therapies — within the 4 weeks before the study treatment starts.
• People who have taken prednisone at a dose above 10 mg per day (or an equivalent steroid) within the 2 weeks before registration.
• People who have received immunotherapy or a treatment called Lu-177 PSMA radioligand therapy within the 6 weeks before registration.
• People who have received palliative radiotherapy within the 2 weeks before registration.
• People whose imaging scans show the cancer has spread to the liver.
• People who have used narcotic pain medicines (including tramadol or stronger) for cancer-related pain within the 4 weeks before signing the consent form.
• People who have an active autoimmune disease that requires daily steroid medication above the equivalent of 10 mg of prednisone.
• People with a currently active HIV, Hepatitis B, Hepatitis C, or HTLV-1 infection (people with a past infection that is fully in remission may be assessed individually by the lead investigator).
• People who have an active infection requiring intravenous antibiotics, or who have had a fever within 1 week before registration.
• People whose life expectancy is estimated to be less than 6 months at the time of signing the consent form.
• People with any other medical condition or circumstance that, in the opinion of the lead investigator, could interfere with safely completing the study.

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