NCT06838520Not yet recruiting
Effect of ADT and ARPI on Bone Loss of Patients with Prostate Cancer
A Prospective Study on the Impact of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI) on Bone Loss in Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT06838520
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Apr 2025 to the primary completion date, 31 Dec 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having previously received androgen deprivation therapy (ADT) or other pharmacological treatments (e.g., denosumab, bisphosphonates, or corticosteroids).
Other illness
- Suffering from double primary malignancies.
- Having known bone diseases.
- Having poor general condition (i.e., ECOG ≥ 4).
Lab values
- Having elevated serum PSA levels (≥4 ng/dL) or testosterone levels (≥50 ng/dL) after 6 months of ADT.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.