Objective  To observe the clinical effect of the "Jianpi Lishi Huayu Decoction" combined with androgen receptor inhibitor or androgen synthesis inhibitors+gonadotropin-releasing hormone agonist (MAB) regime in the treatment of hormone-sensitive prostate cancer (HSPC).

  Methods  One hundred patients with HSPC who visited First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and Tianjin Medical University General Hospital from November 2019 to June 2021 were randomly assigned into the treatment and control groups (50 patients each). Patients in the control group were treated with MAB regime, while those in the treatment group were treated with MAB and the "Jianpi Lishi Huayu Decoction". The main outcome measures were median progression-free survival (mPFS) and prostate specific antigen (PSA) levels. Secondary outcome measures were serum testosterone levels, traditional Chinese medicine (TCM) clinical symptom score, EORTC QLQ-C30, and KPS score. Results: Compared with patients in the control group, those in the treatment group had a longer mPFS by 4 months (16 months vs. 12 months), had significantly reduced PSA levels (P<0.05), showed improved TCM clinical symptom score (P<0.05), showed improved QLQ-C30 (P<0.05), and had improved KPS score (P<0.05). Prognostic factor analysis of subgroups showed that patients with KPS grade 90, PSA minimum ≤1 ng/mL, and PSA decrease ≥90% before treatment benefitted more significantly from the combined treatment of "Jianpi Lishi Huayu Decoction" and MAB.

  Conclusions  The use of "Jianpi Lishi Huayu Decoction" combined with MAB can prolong the mPFS of patients, reduce the level of PSA, achieve the deep response of PSA, reduce the level of serum testosterone to that seen in individuals who have undergone castration, and prolong the time of hormone sensitivity. Improvement in the TCM clinical symptom score of patients with HSPC following this treatment is synonymous with the improvement in the quality of life of these patients.