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NCT04725903 · ClinicalTrials.gov registry record · NA
Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
A NA study of Stage III Prostate Cancer AJCC v8 and Stage IIIA Prostate Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04725903: Recruiting NA study of Stage III Prostate Cancer AJCC v8 and Stage IIIA Prostate Cancer AJCC v8, sponsored by Emory University.
NCT04725903 is a NA study of Stage III Prostate Cancer AJCC v8 and Stage IIIA Prostate Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 30 participants, below the 248-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04725903, a NA study of Stage III Prostate Cancer AJCC v8 and Stage IIIA Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.
Primary Outcome
The rate of grade 2+ gastrointestinal toxicity within 30 days of receiving radiation therapy (RT) will be measured. It will be compared to the theorized reduction to 24% toxicity using the exact binomial test. Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Survey Administration
- RADIATION High-Dose Rate Brachytherapy
- RADIATION Proton Beam Radiation Therapy
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT04725903 shows while recruiting
NCT04725903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 248-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (88% lower).
The record links to 4 conditions, with Stage III Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04725903 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04725903 about?
NCT04725903 is a clinical study titled "Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer". This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastr...
What is the current status of trial NCT04725903?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2021-02-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04725903 study?
This clinical trial studies the following conditions: Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT04725903?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Survey Administration (OTHER), High-Dose Rate Brachytherapy (RADIATION), Proton Beam Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04725903?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04725903 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04725903's enrollment target sits among peer trials
30 22nd of 28 higher than 6 of 28 other Stage III Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Prostate Cancer AJCC v8 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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