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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00887458
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed prostate adenocarcinoma.
* Presence of distant metastases on bone scan, CT scan, or MRI scan.
* Progression after androgen deprivation (and anti-androgen withdrawal).
* Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
* Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
* Age \> 18 years.
* ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.
* Life expectancy \> 6 months.
* Adequate kidney, liver, and bone marrow function.
* Willingness to sign informed consent and adhere to study requirements.
Exclusion Criteria:
* Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
* Previous chemotherapy for metastatic prostate cancer.
* Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
* Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
* History of malabsorption syndrome (may affect itraconazole absorption).
* Allergic reactions to itraconazole or similar compounds.
* Concurrent use of drugs that interact with the CYP3A4 system (caution only).
* Presence of known brain metastases.
* Prior malignancy in the last 3 years, with some exceptions.
* Uncontrolled major infectious, cardiac, or pulmonary illnesses.
* Prolonged corrected QT interval (\> 450 msec) on electrocardiography.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00887458
Study Brief:
Protocol Section:
NCT00887458