Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

NCT06200259 | Recruiting FDA Device

• 1 other identifier: 2023-485 INV
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 Adenocarcinoma; Prostate Carcinoma; Prostate Cancer

Outcome Measures

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.

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

Study Arms (2)

"Spot Delete"

EXPERIMENTAL

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.

Radiation: Spot Delete planning for proton therapy

Control Arm

ACTIVE COMPARATOR

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

Radiation: Traditional proton treatment planning system

Interventions

Traditional proton treatment planning system RADIATION

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

Control Arm

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

Also known as: Pencil beam scanning proton therapy

"Spot Delete"

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pathological proven diagnosis of prostatic adenocarcinoma
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Covenant Health Cancer Center: lead

Study Sites (1)

Thompson Proton Center

Knoxville, Tennessee, 37909, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Samantha Hedrick, PhD, DABR

  Thompson Proton Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Hedrick, PhD, DABR

CONTACT

865-862-1600; shedrick@covhlth.com

Catherine Duke-Taylor, BS

CONTACT

865-862-1600; cduke@CovHlth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 10, 2024
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 2, 2040
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)