Studies bone health in men with prostate cancer on hormone-blocking treatments
Compares bone changes in men with prostate cancer on hormone therapy alone or with ARPI.
Plain-language title generated from the registry record
Registry title: Effect of ADT and ARPI on Bone Loss of Patients with Prostate Cancer
Key facts
- Where
- Changzhou, Nanjing, Suzhou, and Yangzhou, ChinaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06838520, who can take part
Where in China
- The Third Affiliated Hospital of Soochow UniversityChangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaNo longer taking part
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
- Northern Jiangsu People's HospitalYangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06838520
- Record updated
- 20 February 2025
- Original description
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.Read full original descriptionShow less
A Prospective Study on the Impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on Bone Loss in Prostate Cancer Patients
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.
Inclusion: Age ≥ 18 years, male gender; Histologically or cytologically confirmed prostate cancer; Clinical stage of metastatic hormone-sensitive prostate cancer (mHSPC); Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2; Life expectancy ≥ 12 months; Willing and able to provide written informed consent.
Exclusion: Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids); Suffering from double primary malignancies; Having known bone diseases; Having poor general condition (i.e., ECOG ≥ 4); Having elevated serum PSA levels (≥4 ng/dL) or testosterone levels (≥50 ng/dL) after 6 months of ADT; Having osteoporosis at baseline (T-score ≤ -2.5); Having spinal metastases confirmed by imaging (e.g., ECT, MRI, CT, or PSMA PET-CT); Having a life expectancy of less than 12 months.