Status:
RECRUITING
Proton Radiation Therapy for the Treatment of Patients with High Risk Prostate Cancer
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage III Prostate Cancer AJCC V8
Stage IIIA Prostate Cancer AJCC V8
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 nod...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments. SECONDARY OBJECTIVES: I. To determine the rate of acute grade 2+ ge...
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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04725903
Start Date
February 1 2021
End Date
December 31 2026
Last Update
November 14 2024
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322