Proctitis Clinical Trials

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Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathological proven diagnosis of prostatic adenocarcinoma

• History and physical exam to establish clinical staging

• Clinical stage T1-T2c (AJCC 7th edition)

• Prostate specific antigen (PSA) \< 20 ng/mL

• Gleason Score ≤ 7

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1

• Patients must be 18 years of age or older

• Willingness and ability to complete the International Prostate Symptom Score (IPSS) survey and Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Locations
United States
Tennessee
Thompson Proton Center
RECRUITING
Knoxville
Contact Information
Primary
Samantha Hedrick, PhD, DABR
shedrick@covhlth.com
865-862-1600
Backup
Catherine Duke-Taylor, BS
cduke@CovHlth.com
865-862-1600
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2040-01-02
Participants
Target number of participants: 500
Treatments
Experimental: Spot Delete
A unique technique called Spot Delete will be utilized to control the placement of spots during treatment planning, to prohibit proton spots from being placed in the rectum, sigmoid, and small bowel. A specialized computer model will be used to study how the energy of the proton beam (linear energy transfer) is related to rectal and bladder side effects.
Active_comparator: Control Arm
The proton spots that are placed by the treatment planning system are not modified
Sponsors
Leads: Covenant Health Cancer Center

This content was sourced from clinicaltrials.gov