Phase 3 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:

• Men who are at least 18 years old
• Men where prostate cancer is suspected by their doctor, and a template biopsy (a type of prostate tissue sampling procedure) has been planned, based on either a recent MRI scan result or non-imaging risk factors (see below)
• Men whose recent MRI scan (within the past 3 months) showed a result scored as PI-RADS 3 or 4 (meaning the scan found something that may need further investigation)
• Men whose recent MRI scan scored PI-RADS 1 or 2 (meaning the scan did not show clear concern), but whose doctor has recommended a template biopsy based on other risk factors, such as:
  • A persistently high or rising PSA blood test result
  • A high PSA density measurement (a calculation based on PSA level and prostate size)
  • An abnormal finding during a physical prostate examination (such as lumps, hardness, or unevenness felt by the doctor)
  • A strong family history of prostate cancer, including a father or brother with prostate cancer, a relative diagnosed under age 65, multiple affected relatives, or a known inherited gene change such as BRCA1/2 or HOXB13
  • High-risk results from certain specialised prostate cancer blood or urine tests (such as 4Kscore, PHI, or PCA3)
  • Symptoms that may suggest advanced prostate disease, such as urinary blockage or bone pain, or ongoing concern after a previous MRI showed no clear findings
• Men who have never had a prostate biopsy before
• Men who are generally well enough to take part, as assessed by a standard medical fitness scale (ECOG score of 0, 1, or 2) in line with FDA guidelines
• Men who are able to understand the study and are willing to follow all study requirements
• Men who agree to a biopsy procedure (with or without targeted sampling) based on their individual risk, scan results, and other test findings
• Men who are willing and able to follow radiation safety rules set by the treating hospital, to protect those around them, particularly if their partner is pregnant or may become pregnant
• Men who agree to use appropriate contraception measures to avoid their partner becoming pregnant during the study period, in line with the study protocol (confirm specific requirements with the trial site)

Who may not be able to join:

• People who have previously been treated for prostate cancer or have already been diagnosed with clinically significant prostate cancer
• People whose prior scans have already shown obvious signs that cancer has spread to other parts of the body
• People who have previously been diagnosed with any other type of cancer, unless it was a type of skin cancer (basal cell or squamous cell carcinoma) that was treated with the aim of curing it
• People who have had an active prostate infection or signs of a urinary tract infection within the 4 weeks before enrolment
• People who have previously had radiation treatment to the pelvic area
• People whose most recent MRI scan returned a PI-RADS 5 result (the highest level of concern on the MRI scoring scale)
• People who have abnormal physical examination findings or test results during the screening period that the investigator believes could affect safety or the ability to complete the study
• People who are unable or unwilling to understand and sign the informed consent form, or who are unwilling to follow study procedures
• People who are unable to lie flat and still during a PET/CT scan, or who cannot tolerate having that type of scan
• People who are unable or unwilling to undergo a prostate biopsy, or who have known allergies or intolerances to the study drug or its ingredients
• People who have received a radioactive treatment or imaging substance within a period that is less than 10 effective half-lives before receiving the study's imaging agent (confirm specific timeframe with trial site)
• People who are currently taking part in, or plan to take part in, another experimental drug or device trial that falls outside standard care during this study period

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