Status:
RECRUITING
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
Lead Sponsor:
Thompson Cancer Survival Center
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 tech...
Detailed Description
Patients will be randomized into two groups of spot placement. In the experimental arm, "Spot Delete" will be used to prohibit proton spots from being placed in the rectum, sigmoid, and small bowel. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2040
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06200259
Start Date
December 15 2025
End Date
January 2 2040
Last Update
December 18 2025
Active Locations (1)
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1
Thompson Proton Center
Knoxville, Tennessee, United States, 37909