High-dose Rate (HDR) Brachytherapy Boost With Stereostatic Body Radiation Therapy (SBRT) to Prostate and Pelvic Nodes for the Initial Treatment of Unfavorable Intermediate or Higher Risk Prostate Cancer
The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.
• Histopathologically proven diagnosis of local unfavorable intermediate or higher risk prostate cancer as defined by NCCN risk group criteria. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.
• No prior definitive treatment or intervention received.
• Life expectancy of more than 10 years as estimated by the treating physician.
• Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET.
• Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan.
• Greater than or equal to 15% nodal involvement risk predicated on publicly available MSKCC pre-prostatectomy nomogram.
• Karnofsky performance status ≥ 80 within 30 days prior to registration.
• Age ≥ 19 years.
• Clinically determined to be a candidate for HDR brachytherapy.
⁃ Patient must be able to provide study-specific informed consent prior to study entry.