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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT00895466
Eligibility Criteria:
Inclusion Criteria:
* pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
* baseline testosterone levels of \> 4 nmol/l
* baseline PSA level of \> 10 microg/l
* eligible for hormone therapy
* willingness to comply with the protocol conditions and procedures
* willing and able to give informed consent
Exclusion Criteria:
* clinical evidence of distant metastases
* previous hormonal therapy administered specifically for prostatic carcinoma
* development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
* primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
* concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
* concomitant radiotherapy for prostate cancer
* presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion
* simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
* BMI \> 30 kg/square meter
* previous serious reaction to a vaccine such as angioedema or anaphylaxis
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00895466
Study Brief:
Protocol Section:
NCT00895466