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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT01784757
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent (IC) obtained.
* Histologically confirmed adenocarcinoma of prostate
* Progressive metastatic disease
* Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
* Adequate bone marrow, hepatic and renal function
* Able to swallow the ODM-201 whole as a capsule or tablet.
Exclusion Criteria:
* Previous chemotherapy for prostate cancer.
* Known metastases in the brain.
* History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
* Known gastrointestinal condition that can significantly affect the absorption of the study treatment.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01784757
Study Brief:
Protocol Section:
NCT01784757