Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT06838520
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06838520
Study Brief:
Protocol Section:
NCT06838520