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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT00355758
Eligibility Criteria:
Inclusion Criteria:
* For all subjects:
* Men 50 years of age or older.
* Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.
* It has been determined by the treating physician that a prostate biopsy is clinically indicated.
* Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.
For study on treatment effect
* Men with clinically localized prostate cancer (total PSA \< 20 ng/ml and clinical T2b or less).
* Men with organ confined prostate cancer as determined by final pathologic diagnosis.
Exclusion Criteria:
* Exclusion criteria for all subjects:
* Known prostate cancer or prior treatment for prostate cancer.
* Acute prostatitis.
* Untreated urinary tract infection.
* Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.
* Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.
Exclusion Criteria (for study on treatment effect)
* Men with non-organ confined prostate cancer.
* Men with detectable serum PSA levels more than 1 months following radical prostatectomy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT00355758
Study Brief:
Protocol Section:
NCT00355758