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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT03074032
Eligibility Criteria:
Inclusion Criteria:
1. Men aged 18 years and older.
2. Histologically confirmed diagnosis of prostate cancer
3. Castrate level of testosterone in blood serum \< 1,7 nmol/l or \< 50 ng/dl
4. PSA level at screening \> 2 ng/ml
5. Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.
6. The patient's ECOG performance status of 0 - 2
7. Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC
8. The expected survival time of not less than 12 weeks
Exclusion Criteria:
1. Prior anticancer therapy:
* Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia)
* Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening
* Exposure to bisphosphonates is allowed only if the treatment started prior to screening
2. Clinically significant cardiovascular system diseases:
3. Clinically significant central nervous system diseases:
4. History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)
5. Prior or concomitant therapy:
* Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening
* Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening
* Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03074032
Study Brief:
Protocol Section:
NCT03074032