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 are 18 years of age or older
• You have been diagnosed with prostate cancer (a specific type called adenocarcinoma, confirmed by a tissue sample)
• You are physically able to carry out basic daily activities, with only mild limitations at most (confirm with trial site)
• You are receiving ongoing hormone therapy to lower testosterone, either through surgery or medication
• Your testosterone blood level is very low (below 50 ng/dl)
• Your cancer has spread to other parts of the body, confirmed by a CT scan or bone scan
• Your cancer has gotten worse while you were taking a newer type of hormone-blocking drug (such as Abiraterone, Enzalutamide, Darolutamide, or Apalutamide), shown by rising PSA levels or imaging scans
• Your PSA level at screening is at least 1.0 ng/mL
• If you have a tumor that can be safely biopsied, you must agree to provide tissue samples before and during treatment
• You have stopped taking your second-generation hormone-blocking drug for at least 2 weeks before starting the trial
• Certain previous treatments are allowed, as long as your last dose was more than 4 weeks ago (including some vaccines, chemotherapy, radiation, and other prostate cancer drugs)
• Your liver, kidney, and blood counts are within acceptable ranges based on blood tests
• You are willing and able to understand and sign a consent form
• If you are sexually active with a partner who could become pregnant, you agree to use reliable contraception throughout the study and for at least 3 months after your last dose, and you agree not to donate sperm during this time
• If your partner is pregnant or breastfeeding, you agree to either abstain from sex or use a condom every time

Who may not be able to join:

• You have significant pain from your cancer that requires opioid (strong prescription) pain medicines
• Your overall health and ability to function are severely limited (confirm with trial site)
• You need to use a self-inserted urinary catheter to urinate because of a blockage caused by prostate cancer or an enlarged prostate (note: a permanently placed catheter may still be acceptable — confirm with trial site)
• You have an active, uncontrolled infection (some people with HIV, hepatitis B, or hepatitis C may still be eligible under certain conditions — confirm with trial site)
• You have a physical or mental condition that would make it difficult to safely take part in or understand the study
• You are currently taking the blood thinners warfarin, rivaroxaban, or apixaban — unless you are able to switch to an alternative blood thinner before starting (confirm with trial site)
• You had a blood clot event in the past 12 months and are not currently on blood-thinning medication
• You have a red blood cell level that is too high, untreated severe sleep apnea, or poorly controlled heart failure
• You are allergic to sesame seed oil or cottonseed oil
• You have had major surgery within the past 3 weeks, or have not fully healed from a previous surgery
• You have a history of seizures, or have a condition that may increase your risk of seizures (such as a prior stroke affecting the brain, significant brain injury, or a brain blood vessel abnormality)

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