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:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT05303558
Eligibility Criteria:
Inclusion Criteria:
* Participants who have histologically confirmed adenocarcinoma of the prostate
* Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
* Participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (NCCN) prostate cancer guideline (2020 version 1) a. T3a or; b. Grade group 4 or Grade group 5 or; c. Prostate specific antigen (PSA) greater than (\>) 20 nanograms per milliliter (ng/mL)
* Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
* Participants must have received at least one perioperative hormonal therapy pattern as listed below:
1. greater than or equal to (\>=) 3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be less than or equal to (\<=) 2 months; and/or
2. \>= 6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery
Exclusion Criteria:
* Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05303558
Study Brief:
Protocol Section:
NCT05303558