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NCT03098836 · ClinicalTrials.gov registry record · Phase 2
Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
A Phase 2 study, sponsored by Daniel George, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT03098836: Completed Phase 2 study, sponsored by Daniel George, MD.
NCT03098836 is a Phase 2 study that has completed, run by Daniel George, MD. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03098836, a Phase 2 study, has completed, sponsored by Daniel George, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study Summary
The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA \< 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period. Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.
Primary Outcome
Radiographic PFS based on PCWG2 criteria or based on the onset of a skeletal related event. Imaging obtained every 12 weeks. Kaplan-Meier estimate of percentage of participants is reported.
Interventions
- DRUG Prednisone
- DRUG Abiraterone Acetate
- DRUG ARN-509
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 2 |
What the finished NCT03098836 record still lists
NCT03098836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT03098836 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03098836 about?
NCT03098836 is a clinical study titled "Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer". The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve ...
What is the current status of trial NCT03098836?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2017-07-10. Estimated completion is 2024-07-09.
What interventions are being tested in trial NCT03098836?
The interventions under investigation include: Prednisone (DRUG), Abiraterone Acetate (DRUG), ARN-509 (DRUG).
Who is sponsoring clinical trial NCT03098836?
This trial is sponsored by Daniel George, MD, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03098836's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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