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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 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 15 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01041326
The ClinicalTrials.gov registry entry for NCT01041326 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Radical Prostatectomy is the first listed.
NCT01041326 reports 0 study locations.
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.
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