Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
Jonsson Comprehensive Cancer Center
Summary
This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Description
PRIMARY OBJECTIVES: I. To estimate the biochemical progression-free survival (b-PFS) at the 5-year time point after combination therapy of stereotactic body radiotherapy (SBRT) and high dose rate (HDR)-brachytherapy (BT) boost stratified by patients with intermediate and high-risk prostate cancer. II. To estimate the rate of acute \>= grade 3 patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms determined within 90 days after treatment completion, respectively. SECONDARY OBJECTIVES: I. To estimate patient-reported GU symptoms at the end of radiotherapy and within 6, 12, 2…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand a written informed consent document, and the willingness to sign it * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7 * No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelv…
Interventions
- RadiationHigh-Dose Rate Brachytherapy
Undergo HDR-BT
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
Location
- University of California at Los Angeles / Jonsson Comprehensive Cancer CenterLos Angeles, California