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

This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI

Sex

Male

Minimum age

18 Years

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 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 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 judgement of the investigator, would limit compliance with study protocol

• DERIVEDButeau JP, Moon D, Fahey MT, Roberts MJ, Ayati N, Papa N, Murphy DG, Kasivisvanathan V, Dhillon HM, Du YT, Dundee P, Foudoulis J, Hennes D, Hutton AC, Idiare J, Jack G, Kamath S, Lee SN, Lee SF, Lee ST, Leslie S, Levy SM, Link E, Mitchell C, Morigi JJ, Nguyen A, Olphert J, Patel MI, Pattison DA, Pearce A, Perera M, Thanigasalam R, Thomson A, Yaxley J, Thompson J, Hofman MS, Emmett L; PRIMARY2 Trial Investigators. Effect of [68Ga]Ga-PSMA-11 PET-CT in the diagnosis of prostate cancer in men with equivocal or clinically high-risk non-suspicious findings on multiparametric MRI (PRIMARY2): a multicentre, non-inferiority, phase 3, randomised controlled trial. Lancet Oncol. 2026 Jul;27(7):839-848. doi: 10.1016/S1470-2045(26)00120-8. Epub 2026 Jun 10. PMID 42269655
• DERIVEDEmmett L, Papa N, Hope TA, Fendler W, Calais J, Burger I, Eiber M, Barbato F, Moon D, Counter W, John N, Xue A, Franklin A, Thompson J, Rasiah K, Frydenberg M, Yaxley J, Buteau J, Agrawal S, Ho B, Nguyen A, Liu V, Lee J, Woo H, Hsiao E, Sutherland T, Perry E, Stricker P, Hofman MS, Kasivisvanathan V, Roberts M, Murphy D. Beyond Prostate Imaging Reporting and Data System: Combining Magnetic Resonance Imaging Prostate Imaging Reporting and Data System and Prostate-Specific Membrane Antigen-Positron Emission Tomography/Computed Tomography PRIMARY Score in a Composite (P) Score for More Accurate Diagnosis of Clinically Significant Prostate Cancer. J Urol. 2024 Aug;212(2):299-309. doi: 10.1097/JU.0000000000004010. Epub 2024 May 17. PMID 38758680
• DERIVEDButeau JP, Moon D, Fahey MT, Roberts MJ, Thompson J, Murphy DG, Papa N, Mitchell C, De Abreu Lourenco R, Dhillon HM, Kasivisvanathan V, Francis RJ, Stricker P, Agrawal S, O'Brien J, McVey A, Sharma G, Levy S, Ayati N, Nguyen A, Lee SF, Pattison DA, Sivaratnam D, Frydenberg M, Du Y, Titus J, Lee ST, Ischia J, Jack G, Hofman MS, Emmett L. Clinical Trial Protocol for PRIMARY2: A Multicentre, Phase 3, Randomised Controlled Trial Investigating the Additive Diagnostic Value of [68Ga]Ga-PSMA-11 Positron Emission Tomography/Computed Tomography in Men with Negative or Equivocal Multiparametric Magnetic Resonance Imaging for the Diagnosis of Clinically Significant Prostate Cancer. Eur Urol Oncol. 2024 Jun;7(3):544-552. doi: 10.1016/j.euo.2023.11.008. Epub 2023 Dec 6. PMID 38061976