NCT06200259Recruiting
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 13 Dec 2023
- Start date
- 15 Dec 2025
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- Covenant Health Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT06200259
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 15 Dec 2025 to the primary completion date, 31 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the pelvic area
- Prior prostate cancer therapy: cryotherapy or hyperthermia
- Prior systemic therapy (chemotherapy) for prostate cancer
Other illness
- Active diverticulitis, ulcerative colitis, or Crohn's disease
Other
- Regional lymph nodes (common iliac, external iliac, internal iliac, presacral) are a target of treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thompson Proton Center Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.