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
Single group
High-Dose Rate Brachytherapy
RadiationReceive high-dose rate brachytherapy boost
Proton Beam Radiation Therapy
RadiationUndergo proton beam therapy
Quality-of-Life Assessment
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Acute grade 2+ gastrointestinal (GI) toxicity
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.
Acute grade 2+ genitourinary (GU) toxicity rate
The rate of grade 2+ genitourinary toxicity within 30 days of receiving radiation therapy (RT) will be measured. Assessments are based on version 5 CTCAE, and the worst severity of GU toxicity will also be assessed.
Optimal frequency of cone beam computed tomography (CT)
Will determine the optimal frequency of cone beam CT during treatment and assess subsequent need for adaptive re-planning. The feasibility of extended-field proton irradiation of high-risk prostate cancer will be estimated using a re-planning rate of less than 10%. The re-planning rate will be estimated as binary variable, yes or no. The exact 95% confidence interval (CI) around the 10 % re-planning count based on the binomial distribution for the estimated 30 patients will be used (0.021-0.265). The study will be deemed feasible if the observed rate is not higher than the upper bound of the estimated 95% CI.
Patient reported health related quality of life (QOL) - PRO-CTCAU GI
Assessed using Patient Reported Outcomes-CTCAE GI toxicity
Patient reported health related quality of life (QOL) - PRO-CTCAU GU
Assessed using Patient Reported Outcomes-CTCAE GU toxicity
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
