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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT04422132
Eligibility Criteria:
Inclusion Criteria:
* Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
* KPS \>=70
* Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan \< 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
* Ability to receive MRI-guided radiotherapy.
* Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
* Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
Exclusion Criteria:
* Prior history of receiving pelvic radiotherapy.
* Patient with inflammatory bowel disease.
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
* History of bladder neck or urethral stricture.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04422132
Study Brief:
Protocol Section:
NCT04422132