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NCT02874014 · ClinicalTrials.gov registry record · Phase 2
Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 2
- Study locations
NCT02874014: Completed Phase 2 study of Prostate Cancer, sponsored by Mayo Clinic.
NCT02874014 is a Phase 2 study of Prostate Cancer that has completed, run by Mayo Clinic. The registered enrollment target is 56 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02874014, a Phase 2 study of Prostate Cancer, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.
Primary Outcome
Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation.
Conditions Studied
Interventions
- RADIATION Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2016-07-25 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 2 |
What the finished NCT02874014 record still lists
NCT02874014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes is the first listed.
NCT02874014 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02874014 about?
NCT02874014 is a clinical study titled "Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer". The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes r...
What is the current status of trial NCT02874014?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2016-07-25. Estimated completion is 2025-04-30.
What conditions does trial NCT02874014 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT02874014?
The interventions under investigation include: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes (RADIATION).
Who is sponsoring clinical trial NCT02874014?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02874014 being conducted?
This trial has 2 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02874014's enrollment target sits among peer trials
56 454th of 735 higher than 281 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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