en.Wedoany.com Reported - A new Phase 3 study in patients with high-risk localized or locally advanced prostate cancer (PCa) has shown that perioperative use of apalutamide provides benefits for those undergoing radical prostatectomy, while PSMA PET imaging played a key role in evaluating androgen receptor inhibitors (ARIs) for perioperative treatment.
The results of this randomized, double-blind, placebo-controlled trial, named PROTEUS, were published in the New England Journal of Medicine. Researchers analyzed data from 2,109 patients (median age 66 years) across 184 institutions in 18 countries. The study authors noted that 1,057 patients received androgen deprivation therapy (ADT) combined with perioperative apalutamide, while the remaining 1,052 patients received ADT and a placebo.
Based on conventional imaging (defined as MRI, computed tomography, or bone scan), no statistically significant difference in metastasis-free survival was observed between the two groups. The researchers subsequently adjusted the study protocol to include PSMA PET in the assessment of distant metastasis. Results showed that, whether assessed by conventional imaging or PSMA PET, the time to distant metastasis was reduced by 32% in the apalutamide group. Five-year metastasis-free survival was achieved in 78.2% of patients in the perioperative apalutamide group, compared to 73.5% in the placebo group. Additionally, the risk of distant metastasis or death was reduced by 20% in the perioperative apalutamide group.
Lead study author Dr. Mary-Ellen Taplin (Professor of Medicine at Dana-Farber Cancer Institute and Harvard Medical School) and colleagues noted: "In our trial, the difference in metastasis-free survival assessed by conventional imaging alone was not significant between groups. The increasing adoption of PSMA PET since the trial's initiation may have limited the ability to assess early disease metastasis-free survival using only conventional imaging. It is recommended that future trials consider the use of PSMA PET to generate results relevant to clinical practice."
Key takeaways from the study include: perioperative apalutamide improves outcomes in patients with high-risk prostate cancer, reducing the risk of distant metastasis or death by 20% when added to ADT compared to placebo; event-free survival was significantly prolonged (57.1 months vs. 38.4 months); and the median time to subsequent therapy was extended by approximately 31 months. PSMA PET is crucial for accurate metastasis assessment, as conventional imaging alone failed to show a statistically significant difference in metastasis-free survival between groups; only after incorporating PSMA PET assessment did the 32% reduction in time to distant metastasis become evident. Five-year metastasis-free survival data support the long-term benefit of apalutamide, with 78.2% in the apalutamide group versus 73.5% in the placebo group.
The study authors found that event-free survival was significantly longer in the perioperative apalutamide group (57.1 months vs. 38.4 months), and the median time to subsequent local or systemic therapy was approximately 31 months longer (74.2 months vs. 41.5 months). Taplin and colleagues added: "Patients enrolled in our trial were assessed according to evolving, up-to-date diagnostic criteria, and the results are broadly applicable to those with high-risk localized or locally advanced prostate cancer undergoing radical prostatectomy."
Regarding study limitations, the authors acknowledged the lack of a comparison between perioperative systemic therapy combined with radical prostatectomy versus radical prostatectomy followed by adjuvant or salvage therapy, as well as the absence of baseline PET imaging.
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