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Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
- 1Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:
- 2Gleason grade 8 or higher
- 3cT3b (seminal vesicle involvement) or cT4
- 4Prostate specific antigen \[PSA\] \> 20 (or PSA \>10 if on finasteride)
- 5Clinically 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
- 6Zubrod performance status 0-2
- 7Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
- 8Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
- 9Platelets \>= 100,000 cells/mm\^3
- 10Hemoglobin \>= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
- 11Patient must be able to provide study specific informed consent
Exclusion Criteria
- 1Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
- 2Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
- 3Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- 4Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
- 5Uncontrolled 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
Locations
1 site participating in this study
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Ardith R. DeShay