The First Affiliated Hospital with Nanjing Medical University
Phase
Observational
Started
2025-04-01
Last updated
2025-02-20
Condition(s) studied
Prostate Cancer (Adenocarcinoma)
Investigational drug(s) / intervention(s)
Bone health assessment
Bone health assessment: Assessments of physical function, DXA scan
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
BMD loss measured at lumbar spine — every 6 months, up to 2 years Measured by bone densitometry
BMD loss measured at hip — every 6 months, up to 2 years Measured by bone densitometry
Trial sites (4)
Facility
City
Region
Status
The Third Affiliated Hospital of Soochow University
Changzhou
Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Northern Jiangsu People's Hospital
Yangzhou
Jiangsu
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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