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New 'Spot Delete' proton therapy aims to spare prostate cancer patients from bowel troubles

NCT ID NCT06200259

Symptom relief Sponsor: Covenant Health Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a technique called 'Spot Delete' during pencil beam scanning proton therapy for low- and intermediate-risk prostate cancer. The goal is to reduce side effects like diarrhea, rectal bleeding, and urinary problems by preventing proton beams from stopping in sensitive areas. Researchers will compare this method to standard proton planning in 500 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pencil beam scanning proton therapy with Spot Delete technique
What this could lead to
If successful, this technique could reduce painful bowel and bladder side effects from proton therapy for prostate cancer patients.
What could go wrong
This is an early-stage technique with no phase designation, and it may not significantly reduce side effects compared to standard planning. Results are based on reported symptoms, not hard outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2040

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma Prostate cancer Prostate carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Thompson Proton Center

    RECRUITING

    Knoxville, Tennessee, 37909, United States

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