This site is now managed by the Commonwealth Department of Health and Aged Care. 

Australian Clinical Trials

Clinical Trial Details

PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

Print record Print record
Trial Information

Broad Health Condition Prostate Cancer

Specific Health Condition

Trial FocusDiagnosis

Recruitment Details

Recruitment status

Recruitment State


Phase of TrialPhase 3

Trial summary

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


Can Healthy volunteers participate? No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Peter MacCallum Cancer Centre, Australia

Trial website

Trial IDNCT05154162

Contact person for information and recruitment