Effect of ADT and ARPI on Bone Loss of Patients with Prostate Cancer

This study aims to assess the impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on bone quality in patients with prostate cancer. Patients undergoing ADT for prostate cancer often experience adverse effects such as decreased bone density and increased fracture risk. While ARPIs are emerging as novel therapeutic agents, their effects on bone quality remain unclear. This study will compare patients receiving combined ADT and ARPI therapy with those receiving ADT alone, evaluating changes in bone density, bone microarchitecture, and bone metabolic markers. The findings will help optimize treatment strategies for prostate cancer patients, reduce the risk of osteoporosis, and improve overall quality of life.

Sex

Male

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

1. Age ≥ 18 years, male gender;
2. Histologically or cytologically confirmed prostate cancer;
3. Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC);
4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
5. Life expectancy ≥ 12 months;
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Suffering from double primary malignancies.
2. Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids).
3. Having osteoporosis at baseline (T-score ≤ -2.5).
4. Having known bone diseases.
5. Having spinal metastases confirmed by imaging (e.g., ECT, MRI, CT, or PSMA PET-CT).
6. Having poor general condition (i.e., ECOG ≥ 4).
7. Having a life expectancy of less than 12 months.
8. Having elevated serum PSA levels (≥4 ng/dL) or testosterone levels (≥50 ng/dL) after 6 months of ADT.

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