Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
Covenant Health Cancer Center
Study ID
NCT06200259
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2030
Completion
Jan 2, 2040

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: "Spot Delete"
    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.
  • Active Comparator: Control Arm
    The proton spots that are placed by the treatment planning system are not modified

Primary Outcome Measure

Test the hypothesis that "Spot Delete" technique in proton therapy reduces late toxicity in low- and intermediate-risk prostate cancer patients [ Time Frame: assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thompson Proton CenterKnoxvilleTennessee37909
Catherine Duke-Taylor, BS
[email protected]
865-331-8216
Jessica M Severt, RN, BSN
[email protected]
865-331-4966
Ryan Grover, MD (SUB_INVESTIGATOR)
Brion Shin, MD (SUB_INVESTIGATOR)
Allen Meek, MD (SUB_INVESTIGATOR)
Chester Ramsey, PhD (SUB_INVESTIGATOR)
Samantha Hedrick, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Knoxville, TN

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Thompson Proton Center· Knoxville, TN

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