Reducing bowel side effects by changing proton beam spot placement for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with low- or intermediate-risk prostate cancer are randomized to two planning approaches for pencil-beam scanning proton therapy: an experimental "Spot Delete" plan that prohibits proton spots from stopping in the rectum, sigmoid, and small bowel, or a control plan using the treatment planning system's default spot placement. Treatment plans are created from CT simulation, dose constraints are kept the same between arms, and a computational model of proton linear energy transfer (LET) is used to study its relationship to rectal and bladder toxicity. Clinical teams will record gastrointestinal and genitourinary toxicities in the electronic medical record and collect patient-reported outcomes (IPSS, EPIC). The goal is to see if spot-placement adjustments can reduce acute or late bowel and bladder side effects without compromising tumor coverage.

Why it matters

Who can join: the full rules

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

Where it's running

• Thompson Proton Center
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Samantha Hedrick, PhD, DABR — Thompson Proton Center
• Study coordinator: Samantha Hedrick, PhD, DABR
• Email: shedrick@covhlth.com
• Phone: 865-862-1600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Lower-dose radiation to parts of the prostate for some men with prostate cancer

  This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07635238

• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

  This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

• Two-fraction radiotherapy for localized prostate cancer

  This study is testing if giving radiotherapy in just two sessions instead of five can effectively treat localized prostate cancer while causing fewer side effects for patients.

  Recruiting UMC Utrecht · Utrecht · NCT06518226

• Radiation therapy for recurrent prostate cancer

  This study is testing a new way to use radiation therapy for men with recurrent prostate cancer to see if it helps control the cancer better while also keeping their quality of life intact.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06392295

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.