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 are male and aged 18 or older.
• People whose general health and ability to carry out daily activities meets a standard level (rated 0 or 1 on a scale used by doctors to measure this).
• People who have been confirmed through lab testing of tissue or cells to have prostate cancer of a specific type (called adenocarcinoma), without certain aggressive features (called neuroendocrine or small cell features).
• People whose cancer has spread widely — either with 4 or more bone tumours (with at least one outside the pelvis or spine), or with cancer that has spread to organs such as the liver or lungs (not just lymph nodes), as shown on scans.
• People who are planned to receive, or are already receiving, hormone therapy to lower testosterone (called androgen deprivation therapy, or ADT) — either through ongoing injections or previous surgical removal of the testicles — alongside 6 cycles of a chemotherapy called docetaxel.
• People whose blood test results show that their bone marrow, liver, kidneys, and heart are functioning at levels that meet specific requirements set by the trial (confirm exact values with trial site).
• People who the trial doctor believes are able to follow the trial plan throughout the study.
• People who are willing to take part and have signed a form showing they understand and agree to participate.

Who may not be able to join:

• People who have previously had certain treatments for prostate cancer — such as chemotherapy, radiation, surgery, or hormone therapy — unless the hormone therapy lasted no more than 3 months with no sign of the cancer worsening, or unless a limited procedure or single course of palliative radiation/surgery was done at least 4 weeks before the trial starts and any side effects have mostly settled.
• People who have previously used, or are planning to use during the trial, certain newer hormone-blocking drugs such as enzalutamide, apalutamide, darolutamide, or abiraterone acetate.
• People who received certain medications in the 4 weeks before the trial starts, including specific drugs that affect hormone levels (such as finasteride or dutasteride), oestrogens, androgens, steroids (except short-term use for allergies), herbal products known to affect prostate cancer or PSA levels (such as saw palmetto), or who were taking part in another clinical trial during that time.
• People who have cancer that has spread to the brain, as seen on imaging scans.
• People who are planned to receive any other cancer treatment during the trial.
• People who have a known allergy or sensitivity to apalutamide, ADT, or any of the chemotherapy components used in this trial.
• People who have difficulty swallowing, ongoing diarrhoea, a bowel blockage, or other conditions that could affect how the body takes in medication.
• People who have a history of seizures (fits), or who have had certain conditions that could cause seizures — such as a mini-stroke, stroke, or a serious head injury — within the 12 months before the trial starts.
• People who have had serious heart problems in the 6 months before the trial starts, such as a heart attack, unstable chest pain, heart failure with symptoms, or irregular heartbeat requiring medication.
• People who have been diagnosed with another cancer in the past 5 years, unless it was a very early-stage cancer that has fully resolved, or a very slow-growing cancer as assessed by the trial doctor.
• People with an active hepatitis B or hepatitis C infection where the virus is present at levels above certain thresholds (confirm specific values with trial site).
• People with a history of immune system deficiency, a positive HIV test, or who have had an organ transplant.
• People who are unwilling to use effective contraception throughout the entire treatment period and for 30 days after the last dose.
• People who the trial doctor believes have other serious health conditions — such as poorly controlled high blood pressure, severe diabetes, or significant neurological or mental health conditions — that could put them at risk or affect the trial results.

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