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 willing to take part and have signed a consent form agreeing to participate
• Men aged 18 or older
• People whose prostate cancer has been confirmed through a tissue or cell sample (biopsy or similar test)
• People whose scans (bone scan, CT, or MRI) show either 4 or more bone metastases (spread to bones), with at least one outside the pelvis or spine, or cancer that has spread to organs (such as the lungs or liver)
• People with either newly diagnosed prostate cancer, or cancer that has come back after previous local treatment, where the cancer still responds to hormone-reducing therapy (ADT)
• People who have been on hormone-reducing therapy (ADT) — either medication or surgical — with or without older-generation hormone-blocking tablets, for no more than 3 months, and whose cancer has not significantly progressed during that time
• People whose planned treatment includes docetaxel (a chemotherapy drug) plus apalutamide and ADT, or apalutamide plus ADT
• People who are generally well and able to carry out everyday activities with no or minimal limitations (as assessed by a standard medical scale)
• People whose blood, liver, kidney, and clotting results fall within acceptable ranges as determined by laboratory tests (confirm specific values with the trial site)
• People of reproductive potential who are willing to use effective contraception throughout the trial and for 6 months after the last dose

Who may not be able to join:

• People whose cancer is located in areas of the prostate that cannot be reached for a type of localised treatment used in this trial
• People with certain prostate calcifications (calcium deposits) or cysts larger than 1 cm in the area that would be treated or scanned
• People with a narrowed urethra, or who have metal or other implants in the urethra
• People who have previously had rectal (bowel) surgery
• People with a history of, or currently having, a rectal fistula (an abnormal opening in the rectum)
• People with rectal narrowing that prevents a transrectal ultrasound scan from being performed
• People whose cancer has grown into the rectum
• People with a current serious urinary tract infection
• People with serious heart or brain blood vessel disease that could make anaesthesia or surgery unsafe
• People who have had an allergic reaction or significant intolerance to any of the drugs used in this trial
• People who are planning to receive other cancer treatments at the same time as this trial
• People who have previously been treated with newer hormone-blocking drugs (such as apalutamide, enzalutamide, or darolutamide), certain other hormone-targeting drugs (such as abiraterone or ketoconazole), chemotherapy, immunotherapy, or certain pre- or post-surgery cancer treatments
• People who have used herbal products that may affect prostate cancer or PSA levels (such as saw palmetto) within the 4 weeks before starting treatment
• People with a history of seizures, who take medications that lower the seizure threshold, or who have had a stroke, mini-stroke (TIA), or a head injury requiring hospitalisation within the past 12 months
• People who have had serious heart problems in the 6 months before treatment, such as a heart attack, severe chest pain, significant heart failure, or a heart rhythm problem requiring medication
• People with conditions that affect the body's ability to absorb oral medication, such as difficulty swallowing, persistent diarrhoea, or bowel obstruction
• People with a weakened immune system (such as those who are HIV-positive or have had an organ transplant)
• People whose cancer has spread to the brain
• People who have had another cancer within the past 5 years (except certain fully treated skin cancers or cervical pre-cancers)
• People who are currently participating in another clinical trial involving an investigational drug or device
• People who are unlikely to be able to follow the trial treatment plan or attend follow-up appointments
• People with other uncontrolled health conditions (such as high blood pressure, diabetes, or mental health conditions) that the trial doctor considers may affect safety or the reliability of the results
• People whom the trial doctor considers unsuitable for any other reason

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