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Background <p>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.</p> Case presentation <p>We present a case series of eight Caucasian/White male patients (aged 58–73&#xa0;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 &gt; 30% radiographic regression per RECIST 1.1 criteria for nodal disease.</p> Mechanistic substudy <p>Tumor biopsies and blood demonstrated strengthened MT1 melatonin receptor expression, synchronous downregulation of Survivin, and elevation of Cystatin C, aligning with clinical biomarker shifts.</p> Conclusions <p>AminoTriComplex was associated with consistent biomarker modulation and occasional exceptional responses; these hypothesis-generating observations warrant validation in larger controlled trials.</p>

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Exceptional and typical biomarker responses to AminoTriComplex in metastatic prostate cancer: a case series

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月4日

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  • Alexandre Tavartkiladze,
  • Gaiane Simonia,
  • Russel J. Reiter,
  • Ruite Lou,
  • Nana Okrostsvaridze,
  • Dinara Kasradze,
  • Pati Revazishvili,
  • Irine Andronikashvili,
  • Pirdara Nozadze,
  • Givi Tavartkiladze,
  • Rusudan Khutsishvili,
  • Tatia Potskhoraia

摘要

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.