Phase 2 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 have been diagnosed with prostate cancer confirmed by a tissue or cell sample, specifically the type called adenocarcinoma, without certain rare aggressive features (neuroendocrine differentiation or small cell features).
• People whose general health and ability to carry out daily activities meets a specific rating scale (ECOG 0 or 1), or who score slightly lower on that scale (ECOG 2) only if the reason is bone pain.
• People with cancer that has spread to other parts of the body (metastatic), confirmed by bone scan, CT scan, MRI, or a special nuclear medicine scan called PSMA-PET — either in a hormone-sensitive stage (mHSPC) or a castration-resistant stage (mCRPC).
• People with hormone-sensitive metastatic prostate cancer (mHSPC) who are expected to live at least 12 months, or people with castration-resistant metastatic prostate cancer (mCRPC) who are expected to live at least 6 months.
• People who are currently receiving hormone-suppressing therapy (called ADT, using a type of medication known as a GnRH analogue) or who have previously had surgical removal of both testicles; for mHSPC, this treatment must have started at least 14 days before the trial begins.
• People with mCRPC who have shown signs that their cancer has grown or progressed, either seen on scans or shown by a rising PSA blood test result meeting specific criteria.
• People with mCRPC who have a very low testosterone level in the blood (below 1.73 nmol/L or 50 ng/dL) at the screening visit.
• People who are able to understand and follow all study instructions and procedures.
• Male participants who agree to use contraception with any female partner who could become pregnant throughout treatment and for 7 months after the last dose of the study drug (ASP5541).
• Male participants who agree to either avoid sexual activity or use a condom with a pregnant partner throughout the study and for 7 months after the last dose of ASP5541.
• Male participants who agree not to donate sperm during treatment and for 7 months after the last dose of ASP5541.
• People who agree not to join another interventional clinical trial while receiving ASP5541.
• People with normal blood potassium levels at the screening visit, without needing potassium supplements.

Who may not be able to join:

• People with another serious illness, active infection, or condition that could interfere with participation or put them at significant risk.
• People with active cancer that has spread to the brain or spinal cord (central nervous system metastases), unless those metastases have already been treated with surgery or radiation and the person is neurologically stable and no longer on high-dose steroid medication for this reason.
• People who have another cancer (in addition to prostate cancer) that currently requires active treatment — with some exceptions, such as certain skin cancers that have been adequately treated, an early-stage (Stage I) cancer in full remission for at least 2 years, or any other cancer from which the person has been cancer-free for at least 5 years.
• People with significant heart conditions, including poorly controlled irregular heartbeats, a genetic heart rhythm condition (congenital long QT syndrome), an abnormally long heart electrical interval on an ECG (QTcF ≥450 msec, with some exceptions for those with pacemakers), significant heart failure, a weakened pumping function of the heart (left ventricular ejection fraction below 50%), or recent chest pain, heart attack, or blood clots in vessels (timeframes vary by study group — confirm with trial site).
• People with high blood pressure that remains uncontrolled despite treatment (thresholds vary depending on which study group — confirm with trial site).
• People with unresolved side effects rated above a certain severity level from previous treatments (above Grade 2 on a standard medical scale), with some exceptions.
• People who have had major surgery requiring general anaesthesia within 30 days before screening, have not fully recovered from surgery, or have major surgery planned during the expected study period.
• People who have had a fever or a significant infection (viral, bacterial, or internal fungal) in the 28 days before the start of the study.
• People who have received a blood transfusion within 1 month before the first dose of the study drug.
• People with a history of problems with the pituitary or adrenal glands (such as Addison's disease or Cushing's syndrome).
• People with poorly controlled diabetes, defined by specific blood sugar marker levels (HbA1c above 10% if previously diagnosed with diabetes, or above 8% if diabetes was not previously diagnosed) — these individuals may be able to re-screen after improving their condition.
• People with jaundice or active liver disease of any kind, including active hepatitis A, B, or C infections confirmed by specific blood tests.
• People with moderate or severe liver impairment (classified as Child-Pugh Class B or C).
• People with a known history of HIV infection.
• People with a body mass index (BMI) above 40 kg/m².
• People with a history of drug or alcohol misuse meeting formal diagnostic criteria within the 2 years before screening.
• People who have taken steroid medications (glucocorticoids) at doses higher than the equivalent of 10 mg of prednisone per day within 4 weeks before the study starts — with exceptions for topical, inhaled, eye, nasal, or joint-injected steroids.
• People who have taken herbal medicines known to affect cancer or the prostate (such as saw palmetto, St. John's wort, or turmeric/curcumin) within 4 weeks before the study starts, or who are not willing to avoid these during the study.
• People currently being treated with certain hormone-blocking medications including ketoconazole (systemic), abiraterone acetate, or similar drugs that block a specific enzyme (CYP17); people who have taken these must have stopped at least 4 weeks before the first dose.
• People who have taken strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inducers or inhibitors) within 4 weeks before the first dose, or who need to continue taking them during the study.
• People who require high-dose biotin (vitamin B7) supplements above 30 μg per day (unless they are able to reduce to 30 μg/day or less before the study starts).
• People who need to take any medication listed on the trial's prohibited medications list.
• For mCRPC participants only: people who have recently received certain prostate cancer treatments within specified timeframes before joining — including hormonal therapies, chemotherapy, biological therapies, immunotherapy, or radiation (including radioligand therapy) — timeframes vary by treatment type (confirm with trial site).
• For mHSPC participants only: people who have received prior treatment for metastatic prostate cancer beyond specific limited exceptions, which include a short course of hormone therapy or surgery, one course of palliative radiation, or up to 6 cycles of a chemotherapy called docetaxel under specific conditions (confirm with trial site).
• People who have taken any other experimental treatment within 4 weeks or 5 half-lives (whichever is longer) before the study starts.
• People who have previously received the study drug ASP5541.
• People whose blood counts or clotting results at screening fall outside required ranges — including low white blood cell counts, low platelet counts, low haemoglobin, or abnormal clotting results (confirm specific values with trial site).
• People with abnormal liver function blood test results at screening above specified levels (confirm with trial site).
• People with poor kidney function, defined as a creatinine clearance below 30 mL/min.
• People with low blood albumin (a protein) levels below 3.0 g/dL at screening.
• People with a known or suspected allergy to ASP5541, prednisone, or any ingredients in the study drug formulations.
• People with a bowel or stomach condition that affects how medications are absorbed.

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