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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT02271659
Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 80 years;
* life expectancy of greater than 10 years;
* prostate adenocarcinoma histologically proven;
* prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2.
* the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
* the signed consent form.
Exclusion Criteria:
* PSA level \> 20;
* Gleason \> 7;
* clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
* prostate volume \> 60 cc;
* pelvic lymph nodes involvement at dissection or imaging (ADP \> 1.5 cm);
* concurrent hormone therapy;
* the presence of distant metastasis (M1);
* history of abdominal or pelvic irradiation;
* history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
* history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
* urinary discomfort with an IPSS (International Prostate Symptom Score) \> 15 (without alpha-blocking);
* inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
* other undergoing study that may interfere with the present study;
* patient under legal protection measure.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02271659
Study Brief:
Protocol Section:
NCT02271659