Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
Recruiting now · Not applicable
Conditions studied: Prostate Cancer, Prostate Adenocarcinoma, Prostate Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06200259
- Run by
- Covenant Health Cancer Center
- People needed
- 500
- Starts
- 2025-12-15
- Expected to finish
- 2040-01-02
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Prior radiotherapy to the pelvic area
- Prior prostate cancer therapy: cryotherapy or hyperthermia
- Prior systemic therapy (chemotherapy) for prostate cancer
- Regional lymph nodes (common iliac, external iliac, internal iliac, presacral) are a target of treatment
- Active diverticulitis, ulcerative colitis, or Crohn's disease
Where it is running
- Thompson Proton Center — Knoxville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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