About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Spot Delete planning for proton therapy
RadiationThe method of adjusting the placement of proton spots or targets that are placed by the treatment planning system during pencil beam scanning for proton therapy
Traditional proton treatment planning system
RadiationIn the control arm, the proton spots placed by the treatment planning system are not modified.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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