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 a specific type of prostate cancer (adenocarcinoma) confirmed by laboratory testing of tissue or cell samples, not including a rare type called small cell prostate cancer
• People who have evidence of prostate cancer that has spread (metastasised) to other parts of the body, confirmed by CT scan, MRI, or bone scan — this includes spread to bones, lymph nodes above a certain point in the abdomen, or organs/soft tissue meeting specific size measurements
• The spread of cancer must be visible on conventional scans (CT, MRI, or bone scan) — detection by PSMA-PET scan alone does not meet this requirement
• People who do not have a specific low-volume pattern of cancer spread (defined as cancer returning after earlier treatment, with 4 or fewer bone metastases and no organ involvement on conventional scans)
• People who have had genetic testing (next generation sequencing) of their tumour tissue completed and results available at the time of joining, from a certified laboratory
• People who have received certain hormone-suppressing treatments (such as LHRH agonists/antagonists, surgical removal of the testicles, first-generation anti-androgens, or certain newer hormone-blocking drugs) within 120 days of joining the trial
• People who have not previously received chemotherapy for prostate cancer
• People aged 18 or older
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning able to carry out some or all daily activities, with or without some limitations)
• People whose blood test results meet specific thresholds for white blood cells, red blood cells, platelets, liver function, kidney function, and potassium levels (confirm specific values with the trial site)
• People with another cancer (past or current) may still be considered eligible, provided that cancer or its treatment is unlikely to interfere with this trial's results (confirm with trial site)
• People who have had cancer spread to the lining around the brain (leptomeningeal metastases) that has been treated, with follow-up brain imaging at least 30 days later showing no sign of worsening
• People living with HIV who are on effective anti-HIV treatment with an undetectable viral level in the 6 months before joining
• People with chronic hepatitis B who have an undetectable viral level while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral level
• People with a heart condition history must be assessed and classified as Class II or better on a standard heart function scale
• People with stable, symptom-free blood clots (deep vein thrombosis) who are on stable blood-thinning medication may be eligible
• Male participants must agree to use a condom during sex for the duration of the trial and for 3 months after the last dose, and must agree not to donate sperm during this period

Who may not be able to join:

• People whose cancer spread is only visible on PSMA-PET scan and not on CT, MRI, or bone scan
• People with cancer that has only spread to lymph nodes within the pelvis (below the aortic bifurcation), with no other metastases
• People who fit the definition of low-volume returning metastatic disease (4 or fewer bone metastases, no organ spread, occurring after earlier curative treatment)
• People whose genetic tumour testing (NGS) was attempted but failed to produce a result
• People who have previously received chemotherapy for prostate cancer
• People who have a history of seizures, or a known condition that may increase the risk of seizures — including a stroke within the past year, a certain type of abnormal blood vessel in the brain, or a condition that required brain surgery or radiation
• People with uncontrolled high blood pressure (resting systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, despite medical treatment)
• People with a known allergic reaction to any of the study drugs or their ingredients
• People currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) — these medications would need to be stopped before joining (confirm timing with trial site)
• People currently taking medications known to lower the seizure threshold — these would need to be stopped or switched before joining (confirm with trial site)
• People whose overall health condition, in the opinion of the treating doctor, would make participation unsafe

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