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NCT01434290 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy in Treating Patients With Prostate Cancer
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 255
- Enrollment target
NCT01434290: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT01434290 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 255 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01434290, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 255 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
Primary Outcome
The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year \> 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are trans
Interventions
- RADIATION 36.25 Gy IMRT
- RADIATION 51.6 Gy IMRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2011-09 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 2 |
What the finished NCT01434290 record still lists
NCT01434290 is an interventional study that assigns participants to a tested intervention. The registered 255 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 (92% higher).
The record links to 0 conditions, and to 2 interventions - of which 36.25 Gy IMRT is the first listed.
NCT01434290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01434290 about?
NCT01434290 is a clinical study titled "Radiation Therapy in Treating Patients With Prostate Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. ...
What is the current status of trial NCT01434290?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 255 participants. The study started on 2011-09. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT01434290?
The interventions under investigation include: 36.25 Gy IMRT (RADIATION), 51.6 Gy IMRT (RADIATION).
Who is sponsoring clinical trial NCT01434290?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01434290's enrollment target sits among peer trials
255 218th of 2000 higher than 1,782 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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