Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
Recruiting · NCT04725903 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Emory University Hospital/Winship Cancer Institute - Atlanta, Georgia, United States