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NCT06200259 · ClinicalTrials.gov registry record · NA
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
A NA study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Covenant Health Cancer Center.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT06200259: Recruiting NA study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Covenant Health Cancer Center.
NCT06200259 is a NA study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by Covenant Health Cancer Center. The registered enrollment target is 500 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (18% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06200259, a NA study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Covenant Health Cancer Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
This purpose of this study is to examine the placement of proton spots during pencil beam scanning proton therapy for low and intermediate risk prostate cancer. The researchers will test a unique technique called "Spot Delete" to control the placement of spots during treatment planning. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the rectum, sigmoid, and small bowel, which is thought to be related to acute or late toxicities, such as tenesmus, diarrhea, fecal incontinence, proctitis, and rectal hemorrhage.
Primary Outcome
The effectiveness of the technique will be evaluated by measuring and documenting the degree of GI and GU reactions in patients undergoing proton therapy with the "Spot Delete" technique. Diarrhea, Fecal Incontinence, Proctitis, Rectal Hemorrhage, Hematuria, Urinary Incontinence, Urinary Retention, Urinary Obstruction, Urinary Pain, Urinary Frequency, and Urinary Urgency will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0.
Conditions Studied
Interventions
- RADIATION Spot Delete planning for proton therapy
- RADIATION Traditional proton treatment planning system
Study Locations (1)
Tennessee
- Thompson Proton Center - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-12-15 |
| Est. Completion | 2040-01-02 |
| Phase | NA |
What NCT06200259 shows while recruiting
NCT06200259 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (18% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Spot Delete planning for proton therapy is the first listed.
NCT06200259 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06200259 about?
NCT06200259 is a clinical study titled "Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement". This purpose of this study is to examine the placement of proton spots during pencil beam scanning proton therapy for low and intermediate risk prostate cancer. The researchers will test a unique technique called "Spot Delete" to control the placement of spots during treatment planning. They will al...
What is the current status of trial NCT06200259?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2025-12-15. Estimated completion is 2040-01-02.
What conditions does trial NCT06200259 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Prostate Carcinoma.
What interventions are being tested in trial NCT06200259?
The interventions under investigation include: Spot Delete planning for proton therapy (RADIATION), Traditional proton treatment planning system (RADIATION).
Who is sponsoring clinical trial NCT06200259?
This trial is sponsored by Covenant Health Cancer Center, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06200259 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
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 NCT06200259's enrollment target sits among peer trials
500 105th of 735 higher than 623 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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