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Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

RECRUITINGN/ASponsored by Covenant Health Cancer Center
Actively Recruiting
PhaseN/A
SponsorCovenant Health Cancer Center
Started2025-12-15
Est. completion2030-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

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 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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions4

CancerProstate AdenocarcinomaProstate CancerProstate Carcinoma

Locations1 site

Thompson Proton Center
Knoxville, Tennessee, 37909
Catherine Duke-Taylor, BS865-331-8216cduke@CovHlth.com

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