Phase 1 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 are willing to take part voluntarily and sign a consent form showing they understand the trial, its process, and possible side effects
• Men aged 18 or older who weigh at least 50 kg and have a body mass index (BMI) between 19 and 30
• Men diagnosed with prostate cancer (confirmed by tissue testing) who a doctor has determined are suitable for hormone-based treatment — this includes those who have not yet had hormone therapy, those currently on stable treatment with a specific hormone injection called triptorelin acetate, or those who have previously had similar hormone therapy and are assessed as suitable to continue with it
• People with an ECOG performance score of 2 or below — this is a measure of how much a condition limits daily activities (confirm with trial site)
• People expected to live for at least 9 months
• People with adequate blood cell counts and liver and kidney function
• People willing to avoid fathering children, donating sperm, and willing to use one or more non-medication forms of contraception (such as barrier methods or abstinence) from signing the consent form until 6 months after the end of treatment

Who may not be able to join:

• People who have previously had surgical removal of the testicles (surgical castration)
• People with known, suspected, or diagnosed bone marrow suppression (BMS) signs or symptoms (confirm with trial site)
• People who have had another cancer in the past 5 years, other than prostate cancer — with the exception of certain skin cancers (basal cell or squamous cell carcinoma) that were fully removed by surgery
• People who have previously had their adrenal glands or pituitary gland removed, or who have a pituitary gland condition
• People planning to have prostate surgery or another major operation during the study period, unless it is to relieve a urinary blockage
• People who have had or are suspected of having spinal cord compression, or urinary blockages that have caused kidney damage, or who are at risk of developing these conditions
• People with serious heart or blood vessel conditions, including poorly controlled high blood pressure (above 160/100 mmHg despite medication), a history of hypertensive crisis or hypertensive brain injury, a heart attack or significant heart failure in the 6 months before the trial, or certain serious heart rhythm problems that cannot be controlled with medication
• People with Type 1 diabetes, or Type 2 diabetes that is not well controlled (based on a specific blood test result at screening)
• People who test positive for certain infections including active hepatitis B, hepatitis C, HIV, or syphilis (based on specific test results)
• People with a history of severe asthma, severe allergic reactions, severe hives, or swelling caused by fluid under the skin
• People known to be allergic to triptorelin acetate or similar hormone-based medications
• People currently misusing drugs or alcohol (defined as drinking more than 14 units of alcohol per week on average)
• People who have taken certain medications known to affect heart rhythm within 4 weeks (or 5 half-lives, whichever is longer) before the trial begins — including certain heart medications, antipsychotics, methadone, and some antibiotics (confirm specific medications with trial site)
• People who have taken part in another clinical trial and received an experimental drug or device within 1 month before this trial begins
• People who have received any vaccine within 4 weeks before the trial begins
• People who have eaten grapefruit, pomelo, or related products within 48 hours before the trial begins, or who have other factors that may affect how the body processes medication
• People who have donated blood, lost a large amount of blood (200 mL or more), or received certain blood or platelet transfusions within 1 month before the trial begins
• People who have difficulty with blood being drawn from a vein
• People who, in the opinion of the investigator, should not participate for any other reason related to safety or the reliability of trial results

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