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NCT03070886 · ClinicalTrials.gov registry record · Phase 2
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
A Phase 2 study, sponsored by NRG Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 612
- Enrollment target
NCT03070886: Completed Phase 2 study, sponsored by NRG Oncology.
NCT03070886 is a Phase 2 study that has completed, run by NRG Oncology. The registered enrollment target is 612 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (360% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03070886, a Phase 2 study, has completed, sponsored by NRG Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 612 participants
- Enrollment target
Study Summary
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Primary Outcome
Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by prostate specific antigen (PSA) \>= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and
Interventions
- DRUG Docetaxel
- RADIATION External Beam Radiation Therapy
- DRUG Bicalutamide
- DRUG Degarelix
- DRUG Flutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2017-04-05 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 2 |
What the finished NCT03070886 record still lists
NCT03070886 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (360% higher).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT03070886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03070886 about?
NCT03070886 is a clinical study titled "Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery". This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prost...
What is the current status of trial NCT03070886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 612 participants. The study started on 2017-04-05. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT03070886?
The interventions under investigation include: Docetaxel (DRUG), External Beam Radiation Therapy (RADIATION), Bicalutamide (DRUG), Degarelix (DRUG), Flutamide (DRUG).
Who is sponsoring clinical trial NCT03070886?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03070886's enrollment target sits among peer trials
612 53rd of 2000 higher than 1,948 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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