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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00928434
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older.
* Raising PSA after prior treatment failure of localized prostate cancer.
* Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
* Has a screening testosterone within normal range (≥1.5 ng/mL).
* Has Eastern Cooperative Oncology Group score of ≤2.
* Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
* Life expectancy of at least 15 months.
Exclusion Criteria:
* Taken hormone therapy in the last 6 months prior to entering this study.
* Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
* Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Has hypersensitivity towards any component of the study drug.
* Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.
* Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
* Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
* Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
* Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
* Has previously participated in any Degarelix trial.
* Is part of an ongoing trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00928434
Study Brief:
Protocol Section:
NCT00928434