Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer
This study will serve as a component of a larger program investigating the benefits of
stereotactic radiotherapy in patients with metastatic disease.
This particular study will serve as a benchmark analysis.
All patients will receive stereotactic radiotherapy directed at metastatic tumors.
If primary prostate cancer is active and has not previously been treated with radiation
therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended.
The metastatic tumor will be treated at the same time.
Hormone therapy will be recommended for all patients.
Patients will be asked to complete questionnaires at regular intervals.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome.
78 months after radiation treatment
Roi Dagan, MD, MS
University of Florida
United States: Institutional Review Board
|University of Florida Proton Therapy Institute||Jacksonville, Florida 32206|