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Proton Radiation Therapy for High-Risk Prostate Cancer

This study is looking at whether proton radiation therapy, sometimes combined with high-dose rate brachytherapy (a type of internal radiation), is an effective way to treat men with high-risk prostate cancer. Proton radiation therapy uses positively charged particles to target tumors with less radiation spread to healthy tissues. Researchers want to see if this treatment leads to fewer side effects in the stomach and intestines (gastrointestinal toxicity) compared to older radiation methods. The study is open to men aged 18 and older with high-risk prostate cancer, which includes certain stages (Stage III Prostate Cancer AJCC v8, Stage IIIA, IIIB, IIIC) or specific features like a high Gleason grade or PSA level. The main goal is to measure gastrointestinal side effects up to 3 years after treatment. The current status of this study is unclear.

Study design
This is a Phase II interventional study with a planned enrollment of 30 participants.
What's involved
You would receive proton beam therapy daily, Monday through Friday. You might also receive a high-dose rate brachytherapy boost.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would have follow-up visits for up to 3 years.

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NCT04725903

Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer

Recruiting
NAAges 18+InterventionalTreatment
Emory University
~30 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:High-Dose Rate BrachytherapyProton Beam Radiation TherapyQuality-of-Life AssessmentSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute grade 2+ gastrointestinal (GI) toxicity
Measured over Up to 3 years

Conditions

Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Pretesh R Patel · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Pretesh Patel, MD
[email protected]
404-778-3473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:
Gleason grade 8 or higher
cT3b (seminal vesicle involvement) or cT4
Prostate specific antigen \[PSA\] \> 20 (or PSA \>10 if on finasteride)
Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins
Zubrod performance status 0-2
Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
Platelets \>= 100,000 cells/mm\^3
Hemoglobin \>= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
Patient must be able to provide study specific informed consent

Exclusion

Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

What this trial measures

  • Acute grade 2+ gastrointestinal (GI) toxicityUp to 3 years

    The rate of grade 2+ gastrointestinal toxicity within 30 days of receiving radiation therapy (RT) will be measured. It will be compared to the theorized reduction to 24% toxicity using the exact binomial test. Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.