Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Exanthema

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

The proton spots that are placed by the treatment planning system are not modified

The 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

Spot Delete planning for proton therapy

In the control arm, the proton spots placed by the treatment planning system are not modified.

Traditional proton treatment planning system

Samantha Hedrick, PhD, DABR

Catherine Duke-Taylor, BS

Jessica M Severt, RN, BSN

Ryan Grover, MD

Brion Shin, MD

Allen Meek, MD

Chester Ramsey, PhD

Samantha Hedrick, PhD

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.

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. In the control arm, proton spots are placed by the treatment planning system are not modified. Medical staff will document gastrointestinal toxicities (diarrhea, fecal incontinence, proctitis, and rectal hemorrhage) and genitourinary toxicities (hematuria, urinary incontinence, urinary retention, urinary obstruction, urinary pain, urinary frequency, and urinary urgency) in the electronic medical record.

This study carries the same risks as regular proton therapy. Proton therapy, like other cancer treatments, may cause the aforementioned side effects. It is important to note that the "Spot Delete" technique aims to specifically address the bladder and bowel reactions, so there might be a potential reduction in this particular risk. Dose constraints will be the same for each treatment arm. Though not expected, it is theoretically possible that this method may counterintuitively increase side effects involving the bladder or bowel. Likewise, increased side effects in other organs are not expected, but are theoretically possible. For this reason we believe there is clinical equipoise between the two trial arms.

Pathological proven diagnosis of prostatic adenocarcinoma

Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement	NCT06200259	Prostate Cancer Prostate Adenoc... Prostate Carcin...	Spot Delete pla... Traditional pro...	18 Years -	Thompson Cancer Survival Center
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement	NCT06200259	Prostate Cancer Prostate Adenoc... Prostate Carcin...	Spot Delete pla... Traditional pro...	18 Years -	Thompson Cancer Survival Center

Spots Global Cancer Trial Database for spot delete planning for proton therapy