Phase 2 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 who have signed a consent form before the study begins
• Men aged 18 years or older
• People whose general health and ability to carry out daily activities meets a certain level of functioning (confirm with trial site what this means for a specific situation)
• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma) through a tissue sample, and for whom surgery to remove the prostate is considered an option
• People whose prostate cancer has at least one high-risk feature, such as: the tumour has grown beyond the prostate (stage cT3 or cT4); a high aggressiveness score on biopsy (Gleason score of 8, 9, or 10); or a PSA blood test result above 20 ng/mL
• People whose lymph nodes appear cancer-free on a specialised type of scan called a PSMA PET/CT (with some exceptions around borderline findings — confirm with trial site)
• People who are willing to use barrier contraception (such as a condom) plus another effective contraceptive method during sexual activity with a pregnant person or someone who could become pregnant, until one week after completing the study scans
• People whose blood test results during screening show healthy enough levels of red blood cells, white blood cells, and platelets (confirm with trial site for specific values)

Who may not be able to join:

• People with a known allergy or sensitivity to the scan substance used in this trial (18F-flotufolastat)
• People who are unable to receive hormone therapy to reduce testosterone (androgen deprivation therapy)
• People whose prostate cancer has rare or unusual cell types beyond standard adenocarcinoma
• People whose scans show cancer has spread to bones, organs, or lymph nodes in certain areas of the body
• People with significantly reduced kidney function
• People who have previously had radiation treatment for prostate cancer
• People who have experienced serious heart problems — such as a heart attack, severe chest pain, heart failure, or significant irregular heartbeat — within the past 6 months
• People with uncontrolled high blood pressure, uncontrolled diabetes, lung disease requiring oxygen, chronic liver disease, or untreated HIV
• People who have had another type of cancer in the past 5 years (though people who have had certain treated skin cancers may still be eligible — confirm with trial site)
• People with severe or uncontrolled active infections
• People currently receiving chemotherapy or other cancer-killing treatments for a different cancer
• People who would not be able to complete both the second PSMA scan and the surgical procedure required by the study
• People with any other condition that the study doctor considers would make participation unsuitable

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