January 3, 2025
'... Recurrent nonmetastatic hormone-sensitive prostate cancer (nmHSPC) is defined by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy (ADT), and without evidence of metastasis on conventional imaging...'
RELEVANCE TO CLARITY
- Non metastatic hormone-sensitive prostate cancer (nmHSPC ) is a subset of Biochemical Recurrence (BCR) - the patients are part of the same target group that was covered by the PROPELLER Trial (which will be covered by the planned Phase 3 AMPLIFY Trial).
- nmHSPC patients exhibit rising prostate-specific antigen (PSA) levels but have no detectable metastases on conventional imaging. These patients remain responsive to androgen deprivation therapy (ADT) but have a high risk of progression to metastatic disease.
- This brand new (2025) publication seems timely as it highlights an enduring interest in evaluation of the performance of imaging modalities: In this case, this is between Conventional scanning (CTscans, MRI, and bone scan) versus PET CT using PSMA tracer.
- This study used data from the EMBARK study, where a key finding was that many patients classified as nonmetastatic using conventional imaging actually had metastatic disease when assessed with PSMA-PET (such as 68Ga-PSAMA-11)! The lesions were missed.
- We know from PROPELLER (and COBRA) that 64Cu-Sar-bisPSMA's performance is significantly superior to 68-PSMA-11. Many patients classified as nonmetastatic using using SOC tracers (68Ga, 18F) had metastatic disease when assessed with 64Cu-Sar-bisPSMA on same day scanning, and more so on NEXT Day scanning!
RP: Radical Prostatectomy
dRT: definitive Radiotherapy
RP and SRT: Radical prostatectomy and Salvage Radiotherapy
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THE ABSTRACT
Importance
The phase 3 randomized EMBARK trial evaluated enzalutamide with or without leuprolide in high-risk nonmetastatic hormone-sensitive prostate cancer. Eligibility relied on conventional imaging, which underdetects metastatic disease compared with prostate-specific membrane antigen–positron emission tomography (PSMA-PET).
Objective
To describe the staging information obtained by PSMA-PET/computed tomography (PSMA-PET/CT) in a patient cohort eligible for the EMBARK trial.
Design, Setting, and Participants
A post hoc, retrospective cross-sectional study included 182 patients from 4 prospective studies conducted from September 15, 2016, to September 27, 2021. All patients had recurrent prostate cancer after radical prostatectomy (RP), definitive radiotherapy (dRT), or salvage radiotherapy (SRT). Analysis was performed from January 2023 to July 2024.
Results (selected)
- Results of PSMA-PET were positive in 80% of patients (73 of 91) after RP, 92% of patients (36 of 39) after dRT, 85% of patients (44 of 52) after RP and SRT, and 84% of patients (153 of 182) overall.
- PSMA-PET detected any distant metastatic disease in 34% of patients (31 of 91) after RP, 56% of patients (22 of 39) after dRT, 60% of patients (31 of 52) after RP and SRT, and 46% of patients (84 of 182) overall.
- Polymetastatic disease (≥5 lesions) was found in 19% of patients (17 of 91) after RP, 36% of patients (14 of 39) after dRT, 23% of patients (12 of 52) after RP and SRT, and 24% of patients (43 of 182) overall.
Conclusions and Relevance
In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease (≥5 lesions) in 24% of patients, suggesting that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging. The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer. Further studies are needed to assess its independent prognostic value and use for treatment guidance.
Impact of Understaging
Misclassification may exclude patients from appropriate systemic or metastasis-directed therapies, affecting outcomes.
Role of Advanced Imaging
Prostate-specific membrane antigen positron emission tomography (PSMA-PET) has emerged as a superior modality for detecting and staging prostate cancer, addressing the shortcomings of conventional methods.
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The full paper is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2828651
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