Phase 1 Bladder 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:

• Biological males aged 18 or older
• People whose bladder cancer has been identified as possibly not having grown into the bladder muscle (non-muscle invasive), based on a scope procedure or imaging reviewed by a qualified urologist
• People who have had a CT or MRI scan of the abdomen and pelvis within the past 6 months showing no signs of cancer spread to the upper urinary tract or other parts of the body (if swollen lymph nodes or abnormalities were found, a negative biopsy or scope procedure of the upper urinary tract is required before joining)
• People with newly suspected, newly diagnosed, or occasionally returning bladder cancer — where "occasional recurrence" means no more than 2 prior episodes in the 18 months before the current cancer was found
• People with one or more bladder tumours
• People who are generally well enough to carry out everyday activities with little or no limitation (confirm with trial site)
• People whose liver function blood test results fall within acceptable ranges set by the institution (confirm with trial site)
• People whose urine culture shows no significant infection, or who have been treated for an infection and have a confirmed clear result before starting the study drug
• People with a testosterone level of 250 ng/dL or above
• People whose thyroid hormone levels are within the normal range
• People whose white blood cell count is at or above the acceptable minimum level set by the institution
• People who are willing to use a condom during any activity that could pass ejaculate to another person throughout the study and for 130 days after the last dose, and whose female partner is also advised to use a highly effective contraception method; people who agree not to donate sperm during the study and for at least 130 days after the last dose
• People who are able to understand and are willing to sign a written consent form

Who may not be able to join:

• People who have used sex hormone therapies or anti-androgen medications (such as certain hormone-blocking treatments) within the 6 months before joining
• People currently taking warfarin or similar blood-thinning medications (other blood thinners may be permitted — confirm with trial site)
• People currently taking part in another clinical trial involving an experimental treatment
• People with a history of allergic reactions to drugs chemically similar to bicalutamide
• People with a history of bladder cancer that has grown into the muscle, or cancer affecting the urethra, upper urinary tract, or a non-urothelial type of bladder cancer
• People who have previously had radiation therapy to the pelvis, prostate, or rectum
• People with any physical or mental health condition, or personal circumstances, that the trial doctor believes would make participation unsafe or unsuitable
• People with serious or unstable heart conditions, including a recent heart attack, severe chest pain, significant heart failure, uncontrolled high blood pressure, recent blood clots (such as a pulmonary embolism or stroke) requiring ongoing blood thinners, or significant heart rhythm problems
• People whose high blood pressure, high cholesterol, or diabetes is considered uncontrolled in the opinion of the trial doctor
• People who are allergic or sensitive to bicalutamide or its ingredients, or who are unable or unwilling to take hormone therapy
• People who are planning to father a child during the study or within 130 days after the last dose

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