BACKGROUND: Metastatic prostate cancer (mPCa) remains a major cause of mortality in men. AminoTriComplex, a multicomponent phytochemical-melatonin formulation, targets inflammation, extracellular matrix remodeling, androgen receptor signaling, and circadian dysregulation. CASE PRESENTATION: We present a case series of eight Caucasian/White male patients (aged 58-73 years; median 66) with histologically confirmed metastatic castration-resistant prostate cancer (mCRPC) from the active treatment arm of a double-blind, placebo-controlled trial. Patients received AminoTriComplex as adjuvant therapy alongside standard of care. Seven "typical" responders were associated with deep prostate-specific antigen (PSA) declines (79-89%), matrix metalloproteinase-9 (MMP-9) reductions (45-55%), interleukin-6 (IL-6) decreases (55-62%), and universal AR-V7 conversion to negative. One "exceptional" responder (a 62-year-old Caucasian/White man) was associated with a 96% PSA decline, normalization of inflammatory and protease biomarkers, complete AR-V7 clearance, restoration of circadian rhythm, and > 30% radiographic regression per RECIST 1.1 criteria for nodal disease. MECHANISTIC SUBSTUDY: Tumor biopsies and blood demonstrated strengthened MT1 melatonin receptor expression, synchronous downregulation of Survivin, and elevation of Cystatin C, aligning with clinical biomarker shifts. CONCLUSIONS: AminoTriComplex was associated with consistent biomarker modulation and occasional exceptional responses; these hypothesis-generating observations warrant validation in larger controlled trials.
Tavartkiladze et al. (Mon,) studied this question.