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A Phase 2, Randomized, Controlled Trial of Best Systemic Therapy Versus Best Systemic Therapy with Definitive Treatment of the Primary Tumor in Metastatic Prostate Cancer - PubMed

6 hours ago
  • #local therapy
  • #metastatic prostate cancer
  • #clinical trial
  • A Phase 2 randomized trial compared best systemic therapy (BST) alone versus BST plus definitive local treatment (surgery or radiation) in men with de novo metastatic prostate cancer (M1 PCa).
  • The study found no significant improvement in progression-free survival (PFS) with the addition of local therapy (median PFS: 17.9 mo for BST alone vs. 14.8 mo for BST + local therapy).
  • Toxicity was limited, with grade 3 adverse events occurring in 6.7% of the local therapy group and none in the BST-alone group.
  • Predictors of worse outcomes included high-volume disease (CHAARTED criteria), clinical stage cT3b/T4, and the aggressive variant PCa molecular signature (AVPC-MS).
  • The study did not show a statistically significant association between AVPC-MS and overall survival (OS), though it was linked to worse PFS.
  • An ongoing Phase 3 trial (SWOG 1802) is further evaluating the impact of local therapy on OS in this patient population.