NCT05154162Active, not recruitingPhase 3
PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal 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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 25 Oct 2021
- Start date
- 2 Mar 2022
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Diseases
- Prostate cancer
- NCT number
- NCT05154162
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 660
- From 2 Mar 2022 to the primary completion date, 15 Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients who meet any of the following criteria will be excluded from study entry:
- Having a PSA \>20ng/ml
- Having ≥ cT3 on DRE
- Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol
Who the study is looking for
- Patients must meet all the following criteria for study entry:
- Males aged ≥ 18 years at the time of consent
- No previously diagnosed prostate cancer
- No previous prostate biopsy
- 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
- Intention for prostate biopsy
- Willing and able to comply with all study requirements
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Cabrini Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.