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NCT01041326 · ClinicalTrials.gov registry record · Phase 1
Preoperative Radiation Therapy for High Risk Prostate Cancer
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01041326: Completed Phase 1 study, sponsored by Duke University.
NCT01041326 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041326, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
Interventions
- PROCEDURE Radical Prostatectomy
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2005-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01041326 record still lists
NCT01041326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Radical Prostatectomy is the first listed.
NCT01041326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01041326 about?
NCT01041326 is a clinical study titled "Preoperative Radiation Therapy for High Risk Prostate Cancer". This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will rec...
What is the current status of trial NCT01041326?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2005-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01041326?
The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Radiation (RADIATION).
Who is sponsoring clinical trial NCT01041326?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01041326's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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