Clinical trial · Interventional
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spot Delete planning for proton therapy | Radiation | — | UNRESOLVED |
| Traditional proton treatment planning system | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- "Spot Delete"
- description
- 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.
- interventionNames
- Radiation: Spot Delete planning for proton therapy
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- The proton spots that are placed by the treatment planning system are not modified
- interventionNames
- Radiation: Traditional proton treatment planning system
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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