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Proton Spot Placement for Prostate Cancer

This study is looking at a new way to deliver proton therapy for men with low- and intermediate-risk prostate cancer. It compares two methods of planning proton therapy: "Spot Delete" planning and traditional proton treatment planning. The "Spot Delete" method aims to reduce side effects in the rectum, sigmoid colon, and small bowel by preventing proton spots from being placed in these areas. Researchers want to see if this technique can lower the risk of gastrointestinal (stomach and bowel) side effects. You may be able to join if you are a man aged 18 or older with a confirmed diagnosis of prostate adenocarcinoma, a PSA (Prostate Specific Antigen) level below 20 ng/mL, and a Gleason Score of 7 or less. The study will track side effects for up to 10 years.

Study design
This is an interventional study planning to enroll 500 participants. Patients will be randomly assigned to one of two groups for proton spot placement.
What's involved
You will have a CT scan for treatment planning. Medical staff will document any gastrointestinal and genitourinary (urinary system) side effects during treatment and annually for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed annually for up to 10 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06200259

Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

Recruiting
NAAges 18+InterventionalTreatment
Covenant Health Cancer Center
~500 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Spot Delete planning for proton therapyTraditional proton treatment planning system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Test the hypothesis that "Spot Delete" technique in proton therapy reduces late toxicity in low- and intermediate-risk prostate cancer patients
Measured over assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years

Conditions

Prostate Cancer
Prostate Adenocarcinoma
Prostate Carcinoma

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Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Samantha Hedrick, PhD, DABR · PRINCIPAL_INVESTIGATOR · Thompson Proton Center

Who to contact

Samantha Hedrick, PhD, DABR
[email protected]
865-862-1600
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Test the hypothesis that "Spot Delete" technique in proton therapy reduces late toxicity in low- and intermediate-risk prostate cancer patientsassessed at baseline, during treatment, at the end of treatment, and annually up to 10 years

    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.