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:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT01320735
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed advanced PCa meeting the following criteria:
1. Any Tumor, Node 1, Metastasis 0
2. Any Tumor, Node 0, Metastasis 1 \[according to Tumor Node Metastasis classification 2009\]
2. Participants planned for administration of leuprorelin
3. World Health Organization status 0-1
4. Life expectancy at least 2 years
Exclusion Criteria:
1. Contraindications to administration of leuprorelin:
1. Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
2. Surgical castration
2. Hormone-refractory PCa
3. Presence of another malignant tumor (except skin cancer)
4. Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
5. Previous administration of radiotherapy or chemotherapy course within 1 month
6. Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion
7. Extremely high level of PSA (greater than or equal to 1000 ng/ml)
8. Other severe diseases in stage of decompensation
9. Other contraindications, that make the participant's participation impossible (by investigator judgment)
10. Previous enrollment in the present program
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01320735
Study Brief:
Protocol Section:
NCT01320735