Phase 2 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 are 18 years of age or older.
• People who have been diagnosed with prostate cancer (specifically a type called adenocarcinoma), confirmed by a tissue sample.
• People whose cancer has spread to other parts of the body, as shown on a CT scan or bone scan.
• People who are currently on continuous hormone-lowering therapy — either surgical removal of the testicles or ongoing hormone-blocking injections or implants.
• People whose blood testosterone level is below 50 ng/dL (a very low "castrate" level), confirmed by a blood test.
• People whose cancer has gotten worse while on a drug called abiraterone acetate, shown either by rising PSA levels (measured twice, at least one week apart) or by new or growing areas of cancer on scans.
• People whose PSA level at the time of screening is 1.0 ng/mL or higher.
• People whose overall health and ability to carry out daily activities meets a certain minimum standard (confirm with trial site — this is assessed using a scale called ECOG, and a score of 2 or below is required).
• People whose liver is functioning well enough, based on blood tests showing liver enzyme and bilirubin levels within an acceptable range.
• People whose kidneys are functioning well enough, based on a kidney filtration rate of 50 or higher (measured by a standard blood test).
• People whose blood counts are within acceptable ranges — including white blood cells, platelets, and haemoglobin levels.
• People who have previously had other prostate cancer treatments (such as certain vaccines, chemotherapy, radiation, or other hormone-blocking drugs) may still be eligible, as long as the last dose was more than 4 weeks ago.
• People who have stopped taking abiraterone for at least 2 weeks before starting the trial.
• People who have made an attempt to reduce or stop taking prednisone (a steroid) before starting the trial. Those who cannot fully stop may continue on the lowest dose achieved during the weaning process.
• People with a tumour that can be safely biopsied must agree to have biopsies taken before and during treatment, as part of the study schedule.
• People who are sexually active with a partner who could become pregnant must agree to use reliable contraception consistently from the start of screening, throughout the study, and for at least 3 months after the last dose of study medication. Sperm donation must also be avoided during this period.
• People whose partner is pregnant or breastfeeding must agree to abstain from penile-vaginal intercourse or use a condom throughout the study.
• People who are able to understand the study and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

• People who need opioid (strong narcotic) pain medications to manage pain caused by their prostate cancer spreading.
• People whose general health and ability to function in daily life falls below a certain level (ECOG score of 3 or higher).
• People who need to use a catheter they insert themselves to urinate, due to blockage caused by prostate cancer or prostate enlargement. (Note: people who already have a permanently inserted catheter may still be eligible — confirm with trial site.)
• People whose cancer has spread to areas where testosterone therapy could be especially dangerous — for example, cancer near the thigh bone that could cause fractures, severe spinal spread that could compress the spinal cord, or extensive spread to the liver (as assessed by the trial doctor).
• People with an active, uncontrolled infection. People with HIV, hepatitis B, or hepatitis C may be eligible under certain specific conditions — confirm with the trial site.
• People whose physical or mental health condition, in the opinion of the trial doctor, would make it unsafe or difficult to take part or to give informed consent.
• People currently taking the blood-thinning medications warfarin, rivaroxaban, or apixaban. Those who are able to switch to a different blood thinner called enoxaparin before starting the trial may be eligible — confirm with the trial site.
• People who have had a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past 12 months and are not currently being treated with blood-thinning medication.
• People with a haematocrit (a measure of red blood cells) above 51%, untreated severe sleep apnoea, or poorly controlled heart failure.
• People who are allergic to sesame seed oil or cottonseed oil.
• People who have had major surgery requiring general anaesthesia within 3 weeks before screening, or who have not fully recovered from a previous surgery.
• People with significant hearing loss that affects everyday life or that requires a hearing aid.
• People with a history of seizures, or any condition that may increase the risk of seizures (such as a stroke affecting the brain's outer layer, significant brain injury, or a brain blood vessel abnormality).

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