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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01220869
Eligibility Criteria:
Inclusion Criteria:
* 20 years or older
* Has a histological confirmed prostate cancer
* Has a screening serum testosterone above 1.5 ng/mL
* Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2
* Has a screening PSA value of ≥2 ng/mL
* Has a life expectancy of at least 168 days
Exclusion Criteria:
* Current or previous hormone therapy
* Is currently treated with 5-α-reductase inhibitor
* Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
* Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy
* Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
* Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator
* Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT01220869
Study Brief:
Protocol Section:
NCT01220869