Evaluating PSMA PET for Prostate Cancer Diagnosis in Men with Negative MRI

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

This study is testing if a special imaging method called PSMA PET can help men with unclear MRI results find out if they have significant prostate cancer, while also trying to reduce unnecessary biopsies.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Peter MacCallum Cancer Centre, Australia (Academic / other)
• Locations: 6 sites (Sydney, New South Wales and 5 other locations)
• Trial ID: NCT05154162 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the added diagnostic value of PSMA PET imaging for men who have negative or unclear MRI results but are suspected of having significant prostate cancer. It is a phase III, open-label, multi-centre, randomized trial that compares the outcomes of patients undergoing PSMA PET/CT followed by targeted biopsy against those receiving standard care with template biopsy. The study aims to determine the effectiveness of PSMA PET in identifying significant prostate cancer while potentially reducing unnecessary biopsies. The trial will also evaluate the safety and complication rates associated with the different biopsy methods used.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with negative or equivocal MRI results and a clinical suspicion of prostate cancer.

Not a fit: Patients with previously diagnosed prostate cancer or those with high PSA levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses of significant prostate cancer and reduce the need for invasive biopsies.

How similar studies have performed: Other studies have shown promise in using PSMA PET imaging for prostate cancer diagnosis, indicating a potential for success in this approach.

Eligibility 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 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

Where this trial is running

Sydney, New South Wales and 5 other locations

• St Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
• Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
• Austin Health — Melbourne, Victoria, Australia (Recruiting)
• Cabrini Health — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Michael Hofman — Peter MacCallum Cancer Centre, Australia
• Study coordinator: Gaurav Sharma

Conditions Prostate Cancer; Prostate; Cancer; PSMA PET