Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
NCT ID:
NCT03002220
Pre Assignment Details:
Men ≥ 18 years. Signed ICF. mCRPC with bone metastases and asymptomatic progression. Serum testosterone levels ≤ 1.7 nmol/L at screening. Minimum of 24 weeks of treatment with abiraterone acetate or enzalutamide. Ongoing androgen deprivation with luteinizing releasing hormone (LHRH) analogue therapy or bilateral orchiectomy. ECOG score ≤ 1. Life expectancy ≥ 12w. Subject with female partner who is of childbearing potential must use two acceptable methods of birth control.
Recruitment Details:
Between December 2016 (first patient in) and October 2018, 52 (82.5%) men from 63 patients with mCRPC with asymptomatic progression while on abiraterone acetate or enzalutamide were included in the study from 9 sites in Spain.
In the protocol, the information stating that the trial would start in November was mostly an approximation. However, the trial ended up starting the following month.
Study:
NCT03002220
Study Brief:
Results Section:
NCT03002220