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Broad Health Condition Prostate Cancer
Specific Health Condition
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
Key inclusion criteria
Inclusion Criteria: - Patients must meet all the following criteria for study entry: 1. Males aged = 18 years at the time of consent 2. No previously diagnosed prostate cancer 3. No previous prostate biopsy 4. Having undergone MRI within 6 months prior to randomisation and meet one of the following criteria: - PI-RADS 2 AND =1 red flag defined as: - PSA density >0.1 - Abnormal DRE - Strong family history (1 first degree relative or =2 second degree) - BRCA mutation - PSA >10 - PSA doubling time <36 months - PSA velocity >0.75/year - PI-RADS 3 5. Scheduled for prostate biopsy 6. Willing and able to comply with all study requirements Exclusion Criteria: - Patients who meet any of the following criteria will be excluded from study entry: 1. Having a PSA >20ng/ml 2. Having = cT3 on DRE 3. Significant morbidity that, in the judgment of the investigator, would limit compliance with study protocol
Minimum age18 Years