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.
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
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
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator