Phase 4 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 able to give their signed agreement to take part in the study.
• People who are male and aged 18 years or older.
• People who have been diagnosed with a specific type of prostate cancer (adenocarcinoma) confirmed by a tissue or cell sample, without certain rare features (neuroendocrine differentiation or small cell features).
• People whose prostate cancer has stopped responding to hormone-lowering treatment, shown by at least 3 rising PSA blood test results taken at least one week apart while on continuous hormone therapy or after surgical removal of the testicles, with the PSA level at screening being at least 1.0 ng/mL.
• People whose testosterone level in the blood is below a very low threshold (castrate level), achieved through ongoing hormone therapy or surgical removal of the testicles.
• People whose PSA level is doubling within 10 months or less.
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard health performance scale (confirm with trial site).
• People whose kidneys are functioning above a minimum level, as measured by a standard blood test (eGFR greater than 15 mL/min/1.73 m²).
• People whose blood counts at screening meet minimum levels — including red blood cells, white blood cells, and platelets — without having received a blood transfusion or growth factor treatment in the 7 days before that blood test.
• People whose liver function blood tests and kidney waste marker (creatinine) are within acceptable ranges at screening (specific thresholds apply; confirm with trial site), with an exception for people with a condition called Gilbert's disease affecting one of the liver markers.
• People who are sexually active and agree to use a condom during the study and for one week after the last dose, along with their partner using a highly effective contraceptive method, and agree not to donate sperm during this time (unless surgically sterile).

Who may not be able to join:

• People who have had cancer that has spread to other parts of the body (metastases) at any time, or where standard imaging (CT/MRI or bone scan) shows detectable spread within 42 days before starting treatment. (Findings seen only on a PSMA/PET scan but not on standard imaging do not exclude someone, and small pelvic lymph nodes below a certain size and location are also allowed.)
• People with local prostate cancer symptoms serious enough to need medical treatment, such as significant urinary blockage or fluid build-up in the kidneys caused by the cancer.
• People who still have unresolved side effects from previous treatments that are above a mild level at the time of starting the study.
• People with a severe or uncontrolled illness, infection, or other health condition that the treating doctor believes makes participation unsuitable.
• People with a known allergy or sensitivity to the study treatment or any of its ingredients.
• People who have had major surgery within 28 days before starting the study treatment.
• People who have had a stroke, heart attack, severe unstable chest pain, heart bypass surgery, or serious heart failure (classified as Class III or IV) within the 6 months before starting treatment.
• People with poorly controlled high blood pressure (systolic 160 mmHg or higher, or diastolic 100 mmHg or higher) at screening, despite being on blood pressure medication. People with controlled high blood pressure on medication may still be eligible (confirm with trial site).
• People with end-stage kidney disease (eGFR below 15 mL/min/1.73 m²).
• People with a history of another cancer, except: adequately treated skin cancers (basal or squamous cell) or early-stage superficial bladder cancer, 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 is likely to significantly affect how the body absorbs the study treatment.
• People with active, unstable viral hepatitis that requires treatment.
• People with a known HIV infection who also have any of the following: a low CD4+ immune cell count (below 350 cells/μL), a serious HIV-related infection in the past 12 months, being on HIV treatment for less than 4 weeks, a detectable viral load above 400 copies/mL, or who are on HIV or other preventive medications that are expected to interact significantly with the study treatment and cannot safely be switched to alternatives.
• People with any condition that, in the treating doctor's judgement, would prevent them from following the study procedures — for example, being unable to swallow the study treatment.
• People who are unwilling or unable to attend all required study visits and follow all study requirements.
• People who have previously been treated with second-generation hormonal drugs for prostate cancer (such as enzalutamide, apalutamide, darolutamide, or similar), other experimental hormonal treatments, or certain hormone-blocking drugs that target an enzyme called CYP17 (such as abiraterone acetate, ketoconazole, or similar).
• People who have used older-generation hormonal prostate cancer drugs (such as bicalutamide, flutamide, nilutamide, or cyproterone acetate) within 28 days before starting the study treatment.
• People who have used oestrogens or certain prostate-related medications called 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 28 days before starting the study treatment.
• People who have had chemotherapy or immunotherapy for prostate cancer, unless it was given as short-term early treatment that was completed more than 2 years before starting the study.
• People who have been taking steroid medications (such as prednisone) at a dose higher than 10 mg per day within 28 days before starting the study treatment.
• People who have received radiotherapy (including internal radiation or radioactive drugs) within 12 weeks before starting the study treatment.
• People who have received bone-protecting injections or infusions (such as bisphosphonates or denosumab) specifically to prevent cancer-related bone complications within 4 weeks before starting the study treatment. (People taking these medications at a lower dose for osteoporosis prevention may be able to continue.)
• People who have taken part in another clinical drug trial within 28 days before starting the study treatment.

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