Phase 3 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 tissue sample (biopsy).
• People whose prostate cancer has spread to bones or lymph nodes (or both), is no longer responding to hormone-lowering treatment, and has no clear signs of spread to other parts of the body based on CT scan, MRI, and bone scan.
• People whose PSA (a prostate cancer marker measured in blood) is 2 ng/mL or higher at the screening stage.
• People whose treating doctor believes a clinical trial is the most appropriate next treatment option.
• People who have already received all standard life-prolonging treatments that were suitable for them, which includes all of the following where applicable:
  • At least one hormone-blocking drug called an androgen receptor pathway inhibitor (ARPI), and where another ARPI is unlikely to help.
  • At least two courses of chemotherapy using taxane drugs (such as docetaxel or cabazitaxel), unless cabazitaxel was not available or the treating doctor considered a second course too risky due to side effects or previous intolerance.
  • At least one dose of a PSMA-targeted radioligand therapy (such as lutetium-177 PSMA), unless it was unavailable, not accessible, not clinically appropriate, or the treating doctor considered it unsuitable.
  • A PARP inhibitor (a targeted cancer drug), if the person has a known BRCA gene mutation and this treatment was available to them.
• People who have had their testosterone surgically removed (orchiectomy) or are currently receiving ongoing hormone-suppressing therapy (ADT) and will continue it throughout the trial.
• People with a general health and activity level rated 0, 1, or 2 on a standard scale used in cancer trials (ECOG scale, where 0 means fully active and 2 means limited in physical activity but able to care for oneself).
• People whose blood test results meet minimum thresholds for kidney function, liver function, blood cell counts, and platelets (confirm specific values with the trial site).

Who may not be able to join:

• People who have had a serious blood clot in a vein (such as a pulmonary embolism) within the month before starting the trial — though a minor, uncomplicated deep vein clot may not be disqualifying (confirm with trial site).
• People who have an active autoimmune disease within the past 12 months that requires ongoing treatment with immune-suppressing medications such as long-term steroids, methotrexate, or tacrolimus.
• People who have had a fever of 38°C or higher, or an active infection requiring treatment with medication, within 7 days before joining the trial, or who have a fever at the time of starting treatment.
• People who have significant breathing difficulties, particularly those who need more than 2 litres per minute of supplemental oxygen through a nasal tube to keep their oxygen levels stable.
• People who have or have had another cancer (other than the prostate cancer being studied) whose natural course or treatment could affect the trial's ability to measure safety or treatment effectiveness.
• People who have experienced any of the following within the 6 months before starting the trial: a heart attack, severe or unstable chest pain (angina), a significant irregular heart rhythm, moderate-to-severe heart failure, a mini-stroke (transient ischaemic attack), or a stroke.
• People who have previously received any treatment that targets a specific immune cell protein called CD3.

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