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:

• You have been diagnosed with prostate cancer (adenocarcinoma type), confirmed by a tissue biopsy.
• Your prostate cancer has continued to grow or spread even though your testosterone levels are very low (a stage called "castration-resistant prostate cancer"), shown by rising PSA levels.
• A special scan (68Ga-PSMA-11 PET scan) shows a specific low level of a protein marker on your cancer cells (confirm with trial site).
• You have previously been treated with certain newer hormone-blocking drugs (such as abiraterone, enzalutamide, apalutamide, or darolutamide), and it has been at least 2 weeks since you stopped taking them.
• You are generally able to carry out some daily activities, even if you cannot do heavy physical work (rated 0–2 on a standard activity scale).
• You have at least one area of cancer that can be seen and measured on a CT scan and/or bone scan.
• Your blood counts and organ function (blood, liver, and kidneys) meet certain minimum levels, checked by blood tests within the past 28 days.
• You and your partner (if applicable) agree to use two reliable forms of contraception during the trial and for 3 months after the last dose of the study drug.
• You are willing and able to attend all required appointments and follow the trial schedule.

Who may not be able to join:

• You have a serious or unstable medical or psychiatric condition that could affect your safety or your ability to give informed consent.
• Your prostate cancer has a specific rare type called neuroendocrine or small cell prostate cancer.
• You have received any cancer treatment (other than hormone injections to lower testosterone) or radiotherapy within the past 2 weeks.
• You have previously been treated with a type of drug called an HDAC inhibitor (including valproic acid, sometimes used for epilepsy) or a treatment called 177Lu-PSMA-617.
• You still have significant side effects (above a moderate level) from previous cancer treatments, not counting hair loss or stable nerve-related symptoms.
• You have a serious uncontrolled medical condition or an active uncontrolled infection, such as uncontrolled seizures, unstable pressure on the spinal cord, or a psychiatric condition that prevents you from giving informed consent.
• You are HIV-positive and have a low immune cell count (CD4 count below 200).
• You have active Hepatitis B or C infection (a previous Hepatitis C infection may be allowed if a specific test confirms it is no longer active).
• You have had major surgery within the past 2 weeks, or you have not yet fully recovered from a recent surgery.
• You are unable to swallow tablets or capsules, or you have a digestive condition that would stop the study drug from being properly absorbed.
• You have been diagnosed with a blood clot in a vein (deep vein thrombosis) or in the lungs (pulmonary embolism) within the past 6 months.
• You are currently taking warfarin (a blood-thinning medication).
• You have a serious heart condition, such as an uncontrolled irregular heartbeat, a heart attack within the past 12 months, a specific abnormal heart rhythm reading on an ECG, or a inherited heart rhythm disorder (confirm with trial site).

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