Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05179694
Eligibility Criteria:
Inclusion Criteria:
All biopsy-naïve men aged 18 years and over who, during investigation for suspicion of possible prostate cancer, require a prostate biopsy. This includes:
* A PSA value above the age-adjusted upper limit of normal, regardless of the MRI result, OR An abnormal pre-biopsy MRI on a 1.5 Tesla or higher MRI scanner, OR An abnormal prostate DRE (regardless of serum PSA or MRI result)
* Considered suitable to tolerate an LATP biopsy procedure by the local clinical team
* Able to give informed consent
* Able to understand written English to enable completion of study validated patient reported outcome measures (questionnaires).
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
* Any previous prostate biopsy
* Dysuria on the day of biopsy or untreated urinary tract infection (UTI)
* Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate)
* May need enhanced antibiotic prophylaxis: Indwelling catheter, recurrent UTIs
* Previous abdomino-perineal resection (i.e. absent rectum)
* Unable to recline adequately in Lloyd-Davis / lithotomy position (e.g. hip surgery, contractures)
* Unable to have a pre-biopsy MRI (e.g. pacemaker, eGFR \<50, claustrophobia)
* PSA \>50 ng/ml (i.e. locally advanced/metastatic prostate cancer easily detectable by TRUS).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05179694
Study Brief:
Protocol Section:
NCT05179694