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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT02739659
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed adenocarcinoma of the prostate
* No lymph node and distant metastasis
* Age ≥ 20 and \< 85 years of age
* Karnofsky Performance Score ≥70
* No previous pelvic radiation therapy (RT)
* No previous prostatectomy
* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
Exclusion Criteria:
* No pathologically confirmed adenocarcinoma of the prostate
* Pelvic lymph node metastasis (N1)
* Distant metastasis (M1)
* Urinary obstructive symptoms (IPSS \> 20)
* Previous pelvic radiotherapy
* Previous prostatectomy
* Severe systemic disorders
* Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
* Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
* Non conformity of the radiotherapy dose distribution when compared to the dose constraints
* Psychiatric disorders or any other condition that can make unreliable the informed consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT02739659
Study Brief:
Protocol Section:
NCT02739659