Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03311555 · ClinicalTrials.gov registry record · Phase 2
A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)
A Phase 2 study, sponsored by Andrew J. Armstrong, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT03311555 is a Phase 2 study that has completed, run by Andrew J. Armstrong, MD. The registered enrollment target is 39 participants.
The verdict
NCT03311555, a Phase 2 study, has completed, sponsored by Andrew J. Armstrong, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to \>100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.
Interventions
- DRUG Docetaxel
- DRUG Apalutamide
- DRUG Androgen deprivation
- RADIATION Salvage radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-03-28 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03311555
The ClinicalTrials.gov registry entry for NCT03311555 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Andrew J. Armstrong, MD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03311555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03311555 about?
NCT03311555 is a clinical study titled "A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)". The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had t...
What is the current status of trial NCT03311555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2018-03-28. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT03311555?
The interventions under investigation include: Docetaxel (DRUG), Apalutamide (DRUG), Androgen deprivation (DRUG), Salvage radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT03311555?
This trial is sponsored by Andrew J. Armstrong, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.