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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT00868868
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Histologically proven prostate cancer
* Treatment plan is to administer long term ADT (androgen deprivation therapy).
* Patient must currently be treated with ADT for at least 2 weeks before enrollment in trial, and for no more than 6 months. Patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a LHRH analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
* Written informed consent to participate in the trial.
Exclusion Criteria:
* Known hypersensitivity to Zoladex, Casodex (if applicable), or any component of these product, or to other similar agents
* Severe cardiac disease (New York Heart Association class III or greater)
* Severe lung disease
* Uncontrollable pain
* Unstable bone lesion
* Any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg Parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
* Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
* Any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). The patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
* Unwillingness or incapacity to consent to trial participation.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00868868
Study Brief:
Protocol Section:
NCT00868868