Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
Study Overview
Status
Detailed Description
Patients will be randomized into two groups of spot placement. In the experimental arm, "Spot Delete" will be used to prohibit proton spots from being placed in the rectum, sigmoid, and small bowel. In the control arm, proton spots are placed by the treatment planning system are not modified. Medical staff will document gastrointestinal toxicities (diarrhea, fecal incontinence, proctitis, and rectal hemorrhage) and genitourinary toxicities (hematuria, urinary incontinence, urinary retention, urinary obstruction, urinary pain, urinary frequency, and urinary urgency) in the electronic medical record.
This study carries the same risks as regular proton therapy. Proton therapy, like other cancer treatments, may cause the aforementioned side effects. It is important to note that the "Spot Delete" technique aims to specifically address the bladder and bowel reactions, so there might be a potential reduction in this particular risk. Dose constraints will be the same for each treatment arm. Though not expected, it is theoretically possible that this method may counterintuitively increase side effects involving the bladder or bowel. Likewise, increased side effects in other organs are not expected, but are theoretically possible. For this reason we believe there is clinical equipoise between the two trial arms.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha Hedrick, PhD, DABR
- Phone Number: 865-862-1600
- Email: shedrick@covhlth.com
Study Contact Backup
- Name: Catherine Duke-Taylor, BS
- Phone Number: 865-862-1600
- Email: cduke@CovHlth.com
Study Locations
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Tennessee
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Knoxville, Tennessee, United States, 37909
- Recruiting
- Thompson Proton Center
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Contact:
- Jessica M Severt, RN, BSN
- Phone Number: 865-331-4966
- Email: jsevert@covhlth.com
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Sub-Investigator:
- Ryan Grover, MD
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Sub-Investigator:
- Brion Shin, MD
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Sub-Investigator:
- Allen Meek, MD
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Contact:
- Catherine Duke-Taylor, BS
- Phone Number: 865-331-8216
- Email: cduke@CovHlth.com
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Sub-Investigator:
- Chester Ramsey, PhD
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Principal Investigator:
- Samantha Hedrick, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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
Other Names:
|
|
Active Comparator: Control Arm
The proton spots that are placed by the treatment planning system are not modified
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In the control arm, the proton spots placed by the treatment planning system are not modified.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samantha Hedrick, PhD, DABR, Thompson Proton Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-485 INV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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