Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCovenant Health Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Spot Delete planning for proton therapy

    Radiation

    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

  • Traditional proton treatment planning system

    Radiation

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: "Spot Delete"Experimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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