Actively Recruiting
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
Led by Covenant Health Cancer Center · Updated on 2025-12-18
500
Participants Needed
1
Research Sites
733 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of prostatic adenocarcinoma
- Clinical stage T1-T2c based on history and physical exam
- Prostate specific antigen (PSA) less than 20 ng/mL
- Gleason Score of 7 or lower
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
- Male patients 18 years of age or older
- Willing and able to complete IPSS survey and EPIC questionnaire
You will not qualify if you...
- Previous radiotherapy to the pelvic area
- Prior prostate cancer treatments such as cryotherapy or hyperthermia
- Prior chemotherapy for prostate cancer
- Treatment targeting regional lymph nodes (common iliac, external iliac, internal iliac, presacral)
- Active diverticulitis, ulcerative colitis, or Crohn's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909
Actively Recruiting
Research Team
S
Samantha Hedrick, PhD, DABR
CONTACT
C
Catherine Duke-Taylor, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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