PRIMARY2: A phase III, multi-centre, randomised controlled trial investigating the additive diagnostic value of [68Ga]Ga-PSMA-11 PET/CT in men with negative/equivocal MRI in the diagnosis of clinically significant prostate cancer.
- Publisher:
- American Society of Clinical Oncology (ASCO)
- Publication Type:
- C-conference
- Citation:
- Journal of Clinical Oncology, 2023, 41, (6_suppl), pp. tps397-tps397
- Issue Date:
- 2023-02-20
Closed Access
| Filename | Description | Size | |||
|---|---|---|---|---|---|
| buteau-et-al-2023-primary2-a-phase-iii-multi-centre-randomised-controlled-trial-investigating-the-additive-diagnostic.pdf | Published version | 36.2 kB |
Copyright Clearance Process
- Recently Added
- In Progress
- Closed Access
This item is closed access and not available.
TPS397 Background Multi parametric magnetic resonance imaging MRI has an established role for the diagnosis of clinically significant prostate cancer sPCa with superior diagnostic accuracy compared with transrectal ultrasound guided prostate biopsy alone PRIMARY demonstrated significant improvement in sensitivity 97 vs 83 and negative predictive value 91 vs 72 with the addition of 68 Ga Ga PSMA 11 PET CT PSMA PET CT vs MRI alone Furthermore 38 of patients with PI RADS 2 or 3 were true negative on PSMA PET CT a population which may potentially benefit from avoiding transperineal prostate biopsy TPPB We hypothesize that the addition of PSMA PET CT is non inferior to MRI for the detection of sPCa in men with PI RADS 2 3 disease while providing the advantages of reducing unnecessary biopsies and limiting to targeted only TPPB Methods This multi centre two arm randomized controlled phase III trial will recruit 660 men with high clinical suspicion of sPC Participants will be randomized in a 1 1 ratio in permuted blocks stratified by center In the experimental arm participants will undergo a pelvic PSMA PET CT Local and central reviewers will interpret independently based on the PRIMARY Score Participants with a positive result will undergo targeted TPPB whereas those with negative PSMA PET CT will avoid biopsy In the control arm all participants undergo template TPPB Patients will continue follow up for subsequent clinical care for up to two years post randomization Key eligibility criteria include an MRI result of PI RADS 2 with at least one red flag PSA density 0 1 abnormal digital rectal examination DRE strong family history BRCA mutation PSA 10 PSA doubling time 36 months PSA velocity 0 75 year or PI RADS 3 having never undergone a prostate biopsy cT3 on DRE and PSA 20 ng mL The co primary objectives are to estimate the percentage difference in sPCa between the experimental and control arms and the percentage of participants who avoid TPPB in the experimental arm The
Please use this identifier to cite or link to this item: