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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT00582556
Eligibility Criteria:
Inclusion Criteria:
* Must have a histologic diagnosis of adenocarcinoma of the prostate.
* For patients without clinical metastasis treated by surgery, serum PSA values must be \> 0.2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy without clinical metastasis, three consecutive increases in serum PSA must be documented, with at least a one-month interval between values with the final PSA \> 2ng/m as evidence of biochemical PSA failure. P
* Patients who have not had prior primary therapy such as radiation or surgery, are required to have a detectable PSA of at least 0.2 ng/ml.
* Patients with evidence of metastatic disease are eligible irrespective of serum PSA level.
* Prior history of a second malignancy is allowed if treated with curative intent and patient has been free of disease greater than five years
* ECOG performance status of \< 2.
Exclusion Criteria:
* Prior treatment with a GnRH analogue or anti-androgen.
* Evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids, or radiation therapy to bones, within 6 months of study enrollment
* Current or treatment within 4 weeks with estrogen or estrogenic agents (including herbal compound PC-SPES)
* Current or treatment within 4 weeks with herbal compounds for prostate cancer such as PC-SPES or saw palmetto
* Current or treatment within 4 weeks with megestrol
* Current or prior treatment with a bisphosphonate, calcitonin, or other bone resorptive/anabolic agents
* Current use of oral corticosteroids or any such use within the past 6 months
* Current use of potentially bone-toxic anticonvulsants (phenytoin, or carbamazepine)
* History of orchiectomy
* Hypocalcemia
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00582556
Study Brief:
Protocol Section:
NCT00582556