Phase 1 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 have been diagnosed with prostate cancer (a specific type called adenocarcinoma, confirmed by laboratory testing of tissue or cells, without certain aggressive features).
• People whose general health and ability to carry out daily activities falls within a certain range on a standard medical scale (ECOG 0 or 1), or who score slightly lower on that scale only because of bone pain.
• People with prostate cancer that has spread to other parts of the body and is still responding to hormone-lowering treatment (mHSPC), with a life expectancy of at least 12 months, or people whose cancer has stopped responding to hormone-lowering treatment (mCRPC), with a life expectancy of at least 6 months.
• People who are able to understand and follow all study instructions and procedures.
• People whose cancer spread (metastasis) has been confirmed by imaging scans such as a bone scan, CT, MRI, or a specialised nuclear medicine scan called a PSMA-PET.
• People who are currently receiving hormone-lowering treatment (called androgen deprivation therapy or ADT) through regular injections, or who have had surgical removal of both testicles; for those with hormone-sensitive disease, this treatment must have started at least 14 days before the first study dose.
• People with castration-resistant prostate cancer (mCRPC) whose disease has shown clear signs of getting worse, either on imaging scans or through rising PSA blood test results meeting specific criteria.
• People with castration-resistant prostate cancer who have a very low testosterone level in the blood (below a specific threshold) confirmed at the screening visit.
• 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.
• Male participants who agree to either avoid sexual contact or use a condom with any pregnant partner throughout the study and for 7 months after the last dose.
• Male participants who agree not to donate sperm during treatment and for 7 months after the last dose.
• People who have enough muscle mass in a specific area of the hip (ventrogluteal muscle) to receive an injection into that muscle.
• People who agree not to join any other interventional clinical trial while receiving the study drug.

Who may not be able to join:

• People with another serious illness, active infection, or medical condition that could interfere with their ability to participate, put them at significant risk, or make study results difficult to interpret.
• People with active cancer that has spread to the brain or spinal cord (central nervous system), unless it was previously treated with surgery or radiation, is now stable, and no longer requires steroid medications.
• People with another type of cancer currently requiring active treatment, with some exceptions: adequately treated certain skin cancers or non-invasive cancers; a Stage I cancer in remission for 2 or more years; or any other cancer from which the person has been cancer-free for 5 or more years.
• People with significant heart conditions, including poorly controlled irregular heartbeats, a rare inherited heart rhythm condition (congenital long QT syndrome), an abnormal heart rhythm measurement on an ECG at screening, a history of significant heart failure or weak heart pumping function, unstable chest pain or a heart attack within the past 6 months, poorly controlled high blood pressure despite treatment, or a blood clot or stroke within the past 3 months.
• People who have unresolved side effects rated above a certain severity level (Grade 2 or higher on a standard scale) from previous treatments at the time of screening.
• People who have had major surgery requiring general anaesthesia within the past 90 days, have not fully recovered from surgery, or have major surgery planned during the study period.
• People who have had a fever or an active viral, bacterial, or fungal infection (other than a skin fungal infection) in the 28 days before starting the study.
• People who have received a blood transfusion within 1 month before the first study dose.
• People with a history of impaired pituitary or adrenal gland function (such as Addison's disease or Cushing's syndrome).
• People with poorly controlled diabetes, defined by blood sugar control levels above specific thresholds (HbA1c above 10% for known diabetes, or above 8% if diabetes was previously undiagnosed) — though rescreening may be possible after improved control is demonstrated.
• People with jaundice or active liver disease, including active hepatitis A, hepatitis B (confirmed by specific blood tests), or hepatitis C (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 specific diagnostic criteria within the past 2 years.
• People who have recently been treated with corticosteroids (such as prednisone) at doses higher than 10 mg per day within the past 4 weeks (certain topical, inhaled, eye, nasal, or joint-injected forms are permitted).
• People who have used certain traditional Chinese medicines or herbal products with known anti-cancer effects (such as saw palmetto) within the past 4 weeks, or who are unwilling to avoid these during the study.
• People currently taking certain medications that affect hormone production in the body (such as ketoconazole or abiraterone acetate), unless these were stopped at least 4 weeks before the first study dose.
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors) within the past 4 weeks.
• People who require biotin (vitamin B7) supplements at doses higher than 30 micrograms per day (unless they switch to a lower dose before starting the study).
• People who require the use of any other medication listed as prohibited in the study.
• People with castration-resistant prostate cancer (mCRPC) who have recently received certain prostate cancer treatments within specific timeframes, including certain hormonal therapies, chemotherapy, biological therapies, immunotherapy, or radiation (including radioactive treatments), depending on the type of treatment.
• People with hormone-sensitive metastatic prostate cancer (mHSPC) who have received treatments beyond what is specifically permitted by the trial (confirm with trial site for details on what prior treatments are allowed).
• People who have taken any other experimental treatment within 4 weeks or 5 half-lives of the first study dose (whichever is longer).
• People who have previously received the study drug ASP5541.
• People whose blood test results at screening show certain blood cell counts or clotting values outside acceptable ranges (confirm with trial site for specific values).
• People whose liver function blood tests at screening fall outside acceptable ranges (confirm with trial site for specific values), unless a specific inherited condition called Gilbert's disease explains elevated bilirubin.
• People whose kidneys are not functioning well enough, based on a specific calculation of kidney function falling below a set threshold.
• People with low blood protein (albumin) levels at screening.
• People with a known or suspected allergic reaction to the study drug ASP5541, prednisone, or any ingredients in the study medications.
• People with a digestive condition that affects how the body absorbs medications.

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