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No longer recruiting (closed or complete)Last updated: 25 February 2026

PRIMARY2: A study investigating whether the addition of a PSMA PET scan improves the diagnostic experience for men with suspected prostate cancer who have a negative or equivocal MRIProspective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer

Trial purpose

Medical clipboardDiagnostic

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

PRIMARY2

Clinical summary

Summary

People with a clinical suspicion of prostate cancer with PI-RADS 2 or 3 on MRI and who meet the eligibility criteria will be randomly allocated to one of two arms.

Participants in the Experimental Arm would receive a pelvic PSMA PET/CT scan. Patients with PSMA positive results would then undergo a transperineal targeted prostate biopsy, and patients who are PSMA would not.

Participants in the Control Arm of the study will receive standard of care (SOC) diagnosis, which means they will undergo a transperineal template prostate biopsy but not receive additional PSMA PET imaging. 

Conditions

This trial is treating people with suspected prostate cancer and have had an MRI, but not received a biopsy or a cancer diagnosis

Eligibility

Inclusion

  • 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 9 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. Intention for prostate biopsy
    6. Willing and able to comply with all study requirements

Exclusion

  • 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 judgement of the investigator, would limit compliance with study protocol

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Peter MacCallum Cancer Centre, Australia

Scientific Title

Prospective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer

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