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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: Completed Phase 2 study, sponsored by Andrew J. Armstrong, MD.
NCT03311555 is a Phase 2 study that has completed, run by Andrew J. Armstrong, MD. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of subjects with testosterone \>100 ng/dl at 36 months post-Cycle 1 Day 1 without one or more of the following: Serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount; Continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks; Evidence of clin
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 |
What the finished NCT03311555 record still lists
NCT03311555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03311555 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03311555's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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