Proton radiation therapy for high-risk prostate cancer
Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer
NA · Emory University · NCT04725903
This study is testing if proton radiation therapy can effectively treat high-risk prostate cancer while causing fewer side effects than traditional radiation methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Emory University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04725903 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of proton radiation therapy for treating patients with high-risk prostate cancer, specifically targeting the prostate tumor and surrounding lymph nodes. The approach aims to minimize gastrointestinal and genitourinary side effects compared to traditional photon radiation treatments. Patients will receive daily proton beam therapy and may also undergo a high-dose rate brachytherapy boost. Follow-up assessments will be conducted at various intervals to evaluate patient-reported outcomes and toxicity rates.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically confirmed high-risk prostate cancer, such as those with a Gleason score of 8 or higher or clinically positive regional lymph nodes.
Not a fit: Patients with bone metastasis or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to fewer side effects for patients with high-risk prostate cancer while effectively targeting the tumor.
How similar studies have performed: Other studies have shown promising results with proton therapy in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Pretesh R Patel — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Pretesh Patel, MD
- Email: pretesh.patel@emory.edu
- Phone: 404-778-3473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8