Prostate CancerNCT06200259
Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
A study testing Spot Delete planning for proton therapy and Traditional proton treatment planning system in people with Prostate Cancer and Prostate Adenocarcinoma, run by Covenant Health Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Carcinoma
- What is being tested?
- Spot Delete planning for proton therapy and Traditional proton treatment planning system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 2 Jan 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thompson Proton Center
Knoxville, Tennessee, 37909
Catherine Duke-Taylor, BS, 865-331-8216, cduke@CovHlth.com
Jessica M Severt, RN, BSN, 865-331-4966, jsevert@covhlth.com
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Carcinoma
- Being tested
- Spot Delete planning for proton therapy, Traditional proton treatment planning system
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spot Delete planning for proton therapyRadiation
Also called Pencil beam scanning 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 systemRadiation
In the control arm, the proton spots placed by the treatment planning system are not modified.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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 Receives: Radiation: Traditional proton treatment planning system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assessed at baseline, during treatment, at the end of treatment, and annually up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Dec 2025
- Primary completionJan 2030 (estimated)
- Study completion2 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Covenant Health Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Hedrick, PhD, DABR, Principal investigator, Thompson Proton Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200259
- Sponsor's protocol ID
- 2023-485 INV
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement
- ClinicalTrials.gov ID
- NCT06200259
- Acronym / sponsor ID
- 2023-485 INV
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Covenant Health Cancer CenterUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- 2 Jan 2040 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Spot Delete" | Experimental | Radiation: Spot Delete planning for proton therapyA 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. |
| Control Arm | Active comparator | Radiation: Traditional proton treatment planning systemThe proton spots that are placed by the treatment planning system are not modified |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spot Delete planning for proton therapyAlso: Pencil beam scanning proton therapyThe 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 | Radiation | "Spot Delete" |
| Traditional proton treatment planning systemIn the control arm, the proton spots placed by the treatment planning system are not modified. | Radiation | Control Arm |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samantha Hedrick, PhD, DABR principal investigator
Thompson Proton Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spot Delete planning for proton therapy and Traditional proton treatment planning system in people with Prostate Cancer and Prostate Adenocarcinoma, run by Covenant Health Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Hedrick, PhD, DABR (865-862-1600, shedrick@covhlth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.