Phase 3 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 who have been diagnosed with prostate cancer that has spread to other parts of the body (metastatic disease), confirmed either by a tissue or cell sample, or by a very high PSA level (above 100 ng/ml) combined with imaging showing spread.
• People whose metastatic disease was visible on imaging scans (such as bone scan, CT, MRI, or PSMA-PET scan) at the time hormone-blocking treatment (ADT) was started.
• People whose PSA level was at least 2.0 ng/ml before starting ADT (applies to those with a confirmed tissue or cell diagnosis).
• People who have recovered from side effects of any previous treatments before joining, unless those side effects are mild (grade 1 or lower), permanent, or considered not medically significant by the trial doctor.
• People who still have side effects from ADT — such as hot flushes or fatigue at any level — provided those side effects are stable, not getting rapidly worse, and the trial doctor does not consider them a safety concern.
• People who have been on ADT for their metastatic prostate cancer for at least 6 months and no more than 12 months (plus or minus 3 weeks) at the time of joining the trial.
• People who have been taking a specific type of hormone therapy drug (called an ARPI, such as abiraterone, enzalutamide, apalutamide, or darolutamide) for at least 4 months (plus or minus 2 weeks) at the time of joining.
• People who may have previously received radiotherapy to the prostate area or to sites where cancer has spread, provided they have recovered from radiation-related side effects.
• People whose testosterone level in the blood is very low (below 1.7 nmol/L or 50 ng/dL), consistent with effective hormone suppression.
• People whose PSA level is at least 0.2 ng/ml within 28 days of joining the trial.
• People who are considered suitable candidates for docetaxel chemotherapy by their treating doctor.
• People with a general health and activity level rated as ECOG 0, 1, or 2 (ranging from fully active to capable of self-care but limited in physical activity).
• People with adequate blood counts and organ function (such as liver and kidneys), tested within 28 days before joining.
• People who are willing to sign a consent form confirming they understand and agree to take part.
• People who are able to attend all required treatment visits and follow-up appointments.
• People who are able to start the trial treatment within 10 working days of being enrolled.
• People (and their partners) who are able to become pregnant must agree to use medically accepted contraception methods during the trial.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People for whom access to all required trial treatments has been confirmed before enrollment.

Who may not be able to join:

• People whose PSA levels have risen in a specific pattern that indicates the cancer is no longer responding to hormone treatment (confirmed PSA progression — confirm with trial site for exact definition).
• People whose cancer has shown confirmed signs of progressing or worsening on imaging or clinically since starting ADT (unless the trial doctor believes any new changes on scans are due to a treatment response effect rather than true progression).
• People who have previously received taxane chemotherapy (such as docetaxel or cabazitaxel).
• People with grade 2 or worse nerve damage causing numbness, tingling, or pain in the hands or feet (peripheral neuropathy).
• People with a known severe allergic reaction to medicines that contain a substance called polysorbate 80.
• People with serious heart conditions, including unstable chest pain (angina), inflamed heart lining (pericarditis), or a heart attack within the past 6 months.
• People with a history of moderate to severe heart failure (classified as New York Heart Association class III or IV).
• People with other serious uncontrolled illnesses or conditions that the trial doctor believes would make participation unsafe.
• People currently receiving any other cancer treatment besides ADT and an ARPI.
• People who have received a live vaccine within 30 days before joining the trial.
• People with a history of chronic hepatitis B who do not have an undetectable viral load while on appropriate suppressive treatment.
• People with a history of hepatitis C who have not been successfully treated and cured, unless they are currently on hepatitis C treatment and have an undetectable viral load.
• People with a specific aggressive form of prostate cancer called high-grade neuroendocrine or small cell prostate cancer (except in cases where there is no tissue diagnosis but PSA was above 100 ng/ml at diagnosis with imaging evidence of spread).

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