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 signed a consent form showing they understand the study and agree to take part
• Men aged 18 or older
• People who have been diagnosed with prostate cancer confirmed by a tissue or cell sample, specifically the type called adenocarcinoma
• People whose prostate cancer has spread to other parts of the body but still responds to hormone-lowering treatment
• People whose PSA level was above 5 ng/ml when their cancer was first found to have spread
• People whose doctors consider them suitable to continue on both apalutamide and hormone-lowering therapy, and who have no medical reason to avoid a chemotherapy drug called docetaxel
• People who have been taking apalutamide for at least 24 weeks but no more than 30 weeks at the time of joining
• People who started hormone-lowering therapy (ADT) no more than 12 weeks before they began apalutamide
• People whose PSA levels have not dropped to a very low level (called a "deep PSA response") after 24 to 30 weeks on apalutamide (confirm with trial site for exact PSA thresholds)
• People whose cancer has not worsened or progressed while on apalutamide
• People who are tolerating the standard daily dose of apalutamide (240 mg) with no more than mild side effects at the time of joining
• People who are able to swallow apalutamide tablets whole
• People who are generally well enough to carry out light activity and care for themselves (a standard activity score of 0 or 1 on the ECOG scale)
• People whose blood test results at screening meet the required levels for red blood cells, white blood cells, platelets, liver function, and kidney function (confirm specific values with trial site)
• Sexually active men who agree to use a condom throughout treatment and for 3 months after finishing apalutamide or 6 months after finishing docetaxel, and whose female partners of childbearing potential agree to use a highly effective form of contraception during the same periods

Who may not be able to join:

• People whose prostate cancer has a rare cell type called neuroendocrine histology
• People who started apalutamide more than 30 weeks before joining the trial
• People whose cancer has shown signs of getting worse — whether seen on scans, felt physically, or shown through rising PSA levels — at the time of joining
• People whose PSA has already dropped to a very low level (deep PSA response) while on apalutamide before the trial begins
• People who have previously been treated with certain hormone-blocking drugs such as enzalutamide, darolutamide, darolutamide, or abiraterone (previous use of older anti-androgen medicines like bicalutamide is generally allowed)
• People who have previously received chemotherapy or immunotherapy for prostate cancer
• People who have had radiotherapy within 2 weeks before joining the trial
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who cannot receive contrast dye used in both CT scans and MRI scans
• People with a prolonged electrical signal in the heart (called a long QT interval) measured on an ECG, or who have an inherited condition called congenital long QT syndrome
• People who have had a stroke, heart attack, severe chest pain, uncontrolled irregular heartbeat, bypass surgery, or serious heart failure in the 6 months before joining
• People with moderate to severe nerve damage in their hands or feet (peripheral neuropathy grade 2 or higher)
• People with high blood pressure that remains uncontrolled despite treatment (systolic at or above 160 mmHg or diastolic at or above 100 mmHg)
• People with a history of another cancer, unless it was a minor skin cancer that was treated, a very early-stage bladder cancer that had not spread, or any other cancer where treatment finished at least 5 years ago and the person has been cancer-free since
• People with a stomach or bowel condition or procedure that could significantly affect how the study drug is absorbed
• People with active hepatitis B or C, HIV with a detectable viral load, or a chronic liver disease requiring ongoing treatment
• People who are currently in, or have recently been in, another clinical trial involving an experimental medicine (within 28 days or a specified washout period, whichever is longer)
• People with any other serious physical, mental, or social condition that could put them at risk or affect their ability to take part in the study

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