Actively Recruiting
Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
Led by Emory University · Updated on 2026-02-17
30
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.
CONDITIONS
Official Title
Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed high-risk prostate cancer with any of the following: Gleason grade 8 or higher, cT3b or cT4 stage, PSA > 20 (or PSA >10 if on finasteride), or clinically/pathologically positive regional lymph nodes
- Zubrod performance status of 0 to 2
- Complete blood cell counts obtained within 90 days prior to registration
- Absolute neutrophil count of at least 1,500 cells/mm³
- Platelet count of at least 100,000 cells/mm³
- Hemoglobin level of at least 8.0 g/dl (transfusions or interventions allowed to reach this level)
- Ability to provide informed consent specific to the study
You will not qualify if you...
- No bone metastasis detected by bone scan or metabolic imaging before therapy
- No distant lymph node metastasis detected by CT or MRI before therapy
- Previous radical prostate surgery or cryosurgery for prostate cancer
- Prior radiation therapy, including brachytherapy, to the region causing overlap with study radiation fields
- Uncontrolled illnesses such as inflammatory bowel disease, HIV infection, active infections, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
P
Pretesh Patel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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