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 diagnosed with prostate cancer who have been treated with androgen deprivation therapy (a treatment that lowers male hormones) and at least one additional hormone-blocking medication (such as abiraterone, enzalutamide, apalutamide, or darolutamide).
• People whose testosterone (male hormone) levels are at or below 50 ng/dL, meaning the hormone-lowering treatment is working as expected.
• People whose cancer has continued to grow or spread despite hormone-blocking treatments.
• People whose PSA (a prostate cancer marker measured in the blood) has risen on two separate tests taken at least 7 days apart.
• People whose cancer can be measured on a CT scan of the chest, abdomen, or pelvis, or whose cancer shows up on a bone scan.
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations).
• People whose liver is functioning well enough, based on blood test results within acceptable ranges.
• People whose kidneys are functioning well enough, based on a calculated kidney clearance rate of at least 30 mL/min.
• People with acceptable blood cell and immune cell counts, including sufficient white blood cells, platelets, and haemoglobin (red blood cell protein).
• People who agree not to donate blood or sperm during the study and for 90 days after the last dose of the study treatment.
• People with sexual partners who could become pregnant must agree to use highly effective contraception throughout the study.
• People who are able to understand the study and are willing to sign a written consent form agreeing to take part.

Who may not be able to join:

• People who have recently received another experimental (investigational) treatment — specifically within 4 weeks, or within a period shorter than 5 half-lives of that treatment, whichever comes first.
• People who had a low PSA level (10 ng/mL or below) at the start of their cancer diagnosis or at a certain stage of progression, and who also have a high number of bone metastases (20 or more spots where cancer has spread to bone).
• People who are currently enrolled in another clinical trial testing a cancer treatment.
• People experiencing severe, uncontrolled diarrhoea that is causing dehydration or imbalances in body salts that cannot be managed with oral treatments.
• People with a serious, uncontrolled infection rated at Grade 3 or higher on a standard medical severity scale.
• People who have had major surgery within 3 weeks before the start of the study treatment (as determined by the treating doctor).
• People who have not fully recovered from side effects of recent surgery before the study treatment begins.
• People whose prostate cancer has certain specific cell types known as small cell, anaplastic, or neuroendocrine (confirm with trial site).
• People with known active cancer spread to the brain.
• People with known active spread of cancer to the membranes surrounding the brain and spinal cord.
• People taking certain medications that may interact with the study treatment, including MAO inhibitors (must stop at least 10 days before), strong or moderate inhibitors of certain liver enzymes (CYP1A2, CYP3A4, CYP2C19), or certain other cancer drugs (rucaparib, olaparib, or talazoparib), unless these can be stopped at least 2 weeks before starting the study.
• People who are unable to swallow medication.
• People with a known allergic reaction to the ingredients of the study drug GZ17-6.02, which contains curcumin, harmine, and isovanillin.
• People with a known condition affecting the body's ability to absorb medications, or a known blockage in the digestive system.
• People with active, untreated hepatitis B or C.
• People with known liver cirrhosis, active non-alcoholic fatty liver disease, or a related liver condition.
• People whose medical, psychological, or social circumstances, in the opinion of the treating doctor, may put them at greater risk or make it difficult to follow the study requirements.

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