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Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

NCT06200259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-12-18

No results posted yet for this 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.

Conditions

Interventions

RADIATION

Spot Delete planning for proton therapy

The method of adjusting the placement of proton spots or targets that are placed by the treatment planning system during pencil beam scanning for proton therapy

RADIATION

Traditional proton treatment planning system

In the control arm, the proton spots placed by the treatment planning system are not modified.

Sponsors & Collaborators

  • Thompson Cancer Survival Center

    lead OTHER

Principal Investigators

  • Samantha Hedrick, PhD, DABR · Thompson Proton Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2030-01-31
Completion
2040-01-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06200259 on ClinicalTrials.gov