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 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:
🦠 Prostate Cancer 🦠 Prostate Adenocarcinoma 🦠 Prostate Carcinoma
🗓️ Study Start (Actual) 8 January 2024
🗓️ Primary Completion (Estimated) 2 January 2026
✅ Study Completion (Estimated) 2 January 2040
👥 Enrollment (Estimated) 500
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Knoxville, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 December 2023
  • First Submitted that Met QC Criteria 27 December 2023
  • First Posted 10 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 December 2023
  • Last Update Posted 10 January 2024
  • Last Verified December 2023