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 able to give written consent and are able to cooperate with the treatment process.
• People aged 18 or older.
• People with a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer), with tumour tissue available for research, or who are willing to have a biopsy to confirm the diagnosis if tissue is not already available.
• People enrolled in the early dose-finding phase of the trial must have disease that can be biopsied, and must agree to biopsies before and during treatment.
• People whose prostate cancer has spread to other parts of the body and is no longer responding to hormone-lowering treatments (known as metastatic castration-resistant prostate cancer).
• People who have previously been treated with at least 12 weeks of a specific type of hormone therapy (enzalutamide, apalutamide, or darolutamide) and whose cancer has since progressed, or who have received abiraterone but not one of those other drugs (confirm with trial site for the specific pathway that may apply).
• People whose cancer has been shown to be progressing, based on at least two of the following: worsening of soft tissue or organ disease on scans, new or worsening bone disease on scans, or a rising PSA level — as assessed using standard research criteria.
• People with a PSA level of 10 ng/mL or higher.
• People who have had surgical removal of the testicles or who are receiving ongoing hormone-lowering injections to suppress testosterone.
• People with a testosterone level below 50 ng/dL (very low, consistent with castration levels).
• People with a general health and activity score showing they are reasonably functional (confirm with trial site regarding the specific scale used).
• People who are willing to use effective contraception during the trial and for 6 months after the last dose of treatment.
• People who are able to swallow the study medication.
• People who are able to stop taking steroids, or who are taking no more than a low dose of prednisolone (up to 5 mg twice daily, or an equivalent steroid).
• People whose blood counts and organ function test results fall within the ranges required by the trial, as tested within one week before starting (confirm with trial site for specific values).

Who may not be able to join:

• People who have had surgery, chemotherapy, or other cancer treatments within 4 weeks before joining the trial (some hormone therapies are exceptions — confirm with trial site).
• People who are currently taking part in another clinical trial involving an experimental medication, or who have done so within the past 4 weeks.
• People who have had limited-area radiotherapy within 2 weeks, or wide-area radiotherapy within 4 weeks, before joining.
• People with clinical or blood test evidence of certain hormone gland problems, specifically overactive aldosterone production or an underactive pituitary gland.
• People with a history of seizures, brain injury, stroke, brain tumours, cancer that has spread to the brain or its surrounding tissues, or a significant history of alcohol dependence.
• People with a condition that prevents proper absorption of medications taken by mouth.
• People with certain heart-related conditions, including an abnormal heart rhythm measurement on an ECG, significant heart rhythm or electrical conduction problems, risk factors for a specific type of heart rhythm abnormality, or a history in the past 6 months of heart bypass surgery, heart attack, chest pain, significant heart failure, or a mini-stroke. People with uncontrolled low or high blood pressure also may not be able to join (confirm with trial site for specific values).
• People with significant liver disease, including moderate or severe liver impairment, viral hepatitis, current alcohol misuse, or cirrhosis.
• People with any other health condition or allergy that the trial doctors consider makes participation unsafe or that could affect the trial results.
• People who have had another type of cancer within the past 5 years, except for a certain type of treated skin cancer (basal cell carcinoma).
• People who still have significant side effects from previous cancer treatments (with some exceptions such as hair loss or mild nerve symptoms).
• People who are unable to follow the trial procedures and scheduled appointments.
• People whose prostate cancer is predominantly a specific subtype called small cell or neuroendocrine (where more than 20% of cells are this type).
• People with a weakened immune system.
• People with active or uncontrolled autoimmune disease that requires steroid treatment to manage.
• People with a history of blood clots within the 12 months before joining the trial.
• People with serious ongoing non-cancer illnesses, including active infections or other significant health conditions.
• People with a known intolerance or allergy to apalutamide, SX-682, or any ingredients in these medications.
• People with symptoms of COVID-19 or a confirmed current COVID-19 infection.
• People currently taking certain medications that are not permitted in this trial, including some seizure medications, certain antipsychotics, certain antidepressants, certain blood thinners, lithium, and others (confirm with trial site for the full list).
• People with a history of a type of lung inflammation (not caused by infection) that required steroid treatment, or who currently have this condition.
• People with a history of a severe skin reaction to a drug, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or a reaction involving the skin, organs, and immune system (DRESS).

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