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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT04790968
Eligibility Criteria:
Inclusion criteria (surgery cohort):
* High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4
Inclusion criteria (radiotherapy cohort):
* High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4
Exclusion criteria (surgery and radiotherapy cohort):
* Prior history of any other cancer the last 5 years excluding basal cell carcinoma
* Proven metastases in bones or other distant metastases
* General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
* Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
* Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT04790968
Study Brief:
Protocol Section:
NCT04790968