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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01737151
Eligibility Criteria:
Inclusion Criteria:
* Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
* Low-risk disease - Histopathology score (Gleason sum): =\<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: \<10
* Intermediate-risk disease as either:
* Histopathology score (Gleason sum) =\< 6, T-stage (per current American Joint Committee on Cancer \[AJCC\] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) \> 10 but =\< 20; or
* Histopathology score (Gleason sum) 7 with =\< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA \< 10
* Charlson index of comorbidity score =\< 4
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
* Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
* Patients with a history of pelvic irradiation for any reason
* Life expectancy \< 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
* Prior radiation therapy, brachytherapy, or cryotherapy
* Prior surgical procedure involving peri-rectal and peri-prostatic area
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01737151
Study Brief:
Protocol Section:
NCT01737151