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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00635167
Eligibility Criteria:
Inclusion Criteria:
* Men aged 40 - 80 years old
* Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA \> 10. Pathology will be confirmed by at least two reviews
* Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation
* Ability to undergo serial TRUS procedures
* Ability to give informed consent
Exclusion Criteria:
* Subject has known hypersensitivity to octafluoropropane.
* Evidence of distant metastatic disease on staging evaluation
* Previous treatment for prostate cancer, including any form of androgen ablation
* Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous
* Expected life expectancy less than 10 years
* Baseline testosterone \< 200 ng/dL
* Subject with cardiac shunts and elevated pulmonary hypertension
* Subject has worsening or clinically unstable congestive heart failure.
* Subject has acute myocardial infarction or acute coronary syndrome.
* Subject has ventricular arrhythmias or is high risk for arrhythmias.
* Subject has respiratory failure, severe emphysema or pulmonary emboli.
* Subject has a history of cardiac shunt or pulmonary hypertension.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00635167
Study Brief:
Protocol Section:
NCT00635167