Prostate Cancer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | January 2, 2040 |
Est. primary completion date | January 2, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thompson Proton Center | Knoxville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Thompson Cancer Survival Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test the hypothesis that "Spot Delete" technique in proton therapy reduces late toxicity in low- and intermediate-risk prostate cancer patients | The effectiveness of the technique will be evaluated by measuring and documenting the degree of GI and GU reactions in patients undergoing proton therapy with the "Spot Delete" technique. Diarrhea, Fecal Incontinence, Proctitis, Rectal Hemorrhage, Hematuria, Urinary Incontinence, Urinary Retention, Urinary Obstruction, Urinary Pain, Urinary Frequency, and Urinary Urgency will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0. | assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years |
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