SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic P
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited n
| Condition(s) | Biochemically Recurrent Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Recurrent Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prost |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cel |
| Who can participate | Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma at the time of surgery * Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] Criteria 8th edition \[Ed.\]) * PSA post radical prostatectomy ≥ 0.1 and \< 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment * Patients must sign institutional review board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests within the specified time frames * Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration * Patients must be ≥ 18 years old * Prostate can |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Mayo Clinic |
| Locations | Scottsdale, Arizona, United States; Albert Lea, Minnesota, United States; Mankato, Minnesota, United States; Rochester, Minnesota, United States; Eau Claire, Wisconsin, United States; La Crosse, Wisconsin, United States |
| Start date | 2024-01-22 |
| NCT ID | NCT06205316 |
| Official listing | https://clinicaltrials.gov/study/NCT06205316 |