Recruiting

Proton Therapy

Sponsor:

Thompson Cancer Survival Center

Code:

NCT06200259

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spot Delete planning for proton therapy

Traditional proton treatment planning system

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Prostate Carcinoma

Study ID

NCT06200259

Start date

Dec 15, 2025

Status verified date

Dec, 2025

Completion date

Jan 2, 2040

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Spot Delete planning for proton therapy

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

In the control arm, the proton spots 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 and Locations

Central contacts

Samantha Hedrick, PhD, DABR

865-862-1600shedrick@covhlth.com

Catherine Duke-Taylor, BS

865-862-1600cduke@CovHlth.com

Locations

Thompson Proton Center

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Catherine Duke-Taylor, BS

865-331-8216cduke@CovHlth.com

Jessica M Severt, RN, BSN

865-331-4966jsevert@covhlth.com

Principal Investigator:

Samantha Hedrick, PhD

More Information

Sponsor

Thompson Cancer Survival Center

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thompson Cancer Survival Center on 2025-12-18.