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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT01436968
Eligibility Criteria:
Inclusion Criteria include:
* Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
* NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
* High Risk with a single high risk feature is defined as having only one of the following: PSA\>20 ng/ml, Gleason score 8-10, or T3a
* Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
* Planning to undergo standard prostate-only external beam radiation therapy
* ECOG Performance Status 0-2
Exclusion Criteria include:
* Liver disease, including known cirrhosis or active hepatitis
* Patients on systemic corticosteroids (\>10mg prednisone per day) or other immunosuppressive drugs
* Known HIV+ patients
* Regional lymph node involvement or distant metastases
* Patients planning to receive whole pelvic irradiation
* Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
* Patients who had or plan to have orchiectomy as the form of hormonal ablation
* Known sensitivity or allergic reactions to acyclovir or valacyclovir
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01436968
Study Brief:
Protocol Section:
NCT01436968